[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gut-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gut-health":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,44,72,101,127,154,184,213,236,262,290,312,360],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100549384","phase-4-understanding-the-efficacy-of-dietary-supplement-on-fungal-mycobiota-in-healthy-volunteers-a-pilot-study-100549384",false,"NCT06433310","Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study","Inclusion Criteria:\n\n* Male or female adults over the age of 18 years\n\nExclusion Criteria:\n\n* History of a diagnosis of any gastrointestinal condition, such as inflammatory bowel syndrome or disease\n* Antibiotic usage within the past two weeks\n* Antifungal usage within the past month\n* Allergy to L-Phenylalanine or individuals with phenylketonuria (PKU)\n* Adults taking medications known to interact with L-phenylalanine supplements, such as Monoamine Oxidase Inhibitors (MOAI), L-DOPA, and some antipsychotic drugs (complete and extensive drug list will be provided to interested participants during screening)\n* Pregnant or nursing women",true,"ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.",[26,27,28,29,30],"Gut Microbiome","Gut Health","Dietary Supplement","L-Phenylalanine","Phenylpropionic Acid","RECRUITING","2026-06-23",{"date":34,"type":35},"2026-06-26","ACTUAL",{"date":37,"type":35},"2024-10-17",{"date":39,"type":20},"2027-12-31",{"name":41,"class":42},"Weill Medical College of Cornell University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100642375","gutcheck-optimization-of-a-personalized-mobile-health-app-for-survivors-of-gastrointestinal-cancer-100642375","NCT07661017","GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer","Inclusion\n\nSurvivors of GI cancer are eligible if they are:\n\n* ≥18 years old\n* reside in or have received cancer care in Minnesota\n* own a smartphone • consent to install the GutCheck app and discontinue diet tracking in other lifestyle apps (e.g., MyFitness, Fitbit, Noom).\n* are English-speaking\n* have received a GI cancer diagnosis (e.g., esophageal, gastric, colorectal, liver, pancreatic, etc)\n* At least 2 months post-cancer treatment\n\nInclusion criteria for oncology specialists (oncologists, advanced practice providers, nurses, dietitians, and patient navigators) include:\n\n* Have interacted with at least 1 cancer patient or survivor in the past month.\n* Have experience working with electronic health records (EHR).\n\nExclusion\n\n* Currently pregnant (Patient Study ONLY)\n* Pregnancy status may be self-reported by the participant.\n* Individuals who are postmenopausal, surgically sterile, or otherwise unable to become pregnant are not subject to this exclusion.\n* Active cancer or receiving treatment for another cancer.\n* Currently taking or has taken antibiotics in the last 3 months.\n* Diagnosis of inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis), and\u002For celiac disease.\n* Involuntary weight loss of 10% or more of usual body weight within 6 months, or involuntary loss of 5% or more of usual body weight in 1 month.\n\nOncology specialists' exclusion criteria include:\n\n* Unable to participate in an interview",{"count":51,"type":20},200,[53],"NA","There are two components to the study: a patient and a clinician study. The clinician study will include one-hour semi-structured interviews with oncology specialists to identify facilitators and barriers to integrating digital diet interventions into the clinical workflow, and to understand their needs and preferences for digital diet interventions. The patient study aims to investigate initial feasibility, efficacy and acceptability of the GutCheck app and intervention. It will last 9 weeks and involves 2 study visits and 2 active phases with a transition week and optional transition visit between phases. During active phases, participants will be asked to use the GutCheck app every day. Prior to the first active phase, participants will go through informed consent and app training. The first active phase will last two weeks and will focus on tracking participants' diet, gastrointestinal (GI) symptoms, and stress. The data collected during the first active phase will be used to identify any potential trigger foods that may contribute to GI symptoms, but only if the participant reports experiencing GI symptoms. Between active phases, participants will have one Transition Week, where results from the first phase are given to the participants with the option to attend a Transition Week Visit. The second active phase will last four weeks and will involve the message intervention. A single-blind, micro-randomized trial design will be used to repeatedly randomize participants to different intervention combinations, determining both the timing and frequency of intervention message delivery throughout the day. Lastly, there will be an exit visit and interview within a week from the intervention to collect post-intervention measures and ask about the participant's experience with the GutCheck app.",[56,57,58,27,59,60,61],"Gastrointestinal","Mobile Health","Gastrointestinal Symptoms","Gastrointestinal Cancer","Survivorship","GI Cancer","NOT_YET_RECRUITING","2026-06-16",{"date":65,"type":35},"2026-06-22",{"date":67,"type":20},"2026-12",{"date":69,"type":20},"2030-06",{"name":71,"class":42},"Masonic Cancer Center, University of Minnesota",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":43},"100640341","a-study-evaluating-the-impact-of-regular-fodmap-targeting-digestive-enzyme-blend-use-on-gastrointestinal-symptoms-in-individuals-with-self-reported-bloating-100640341","NCT07591584","A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating","Inclusion Criteria:\n\n* Individuals aged 18 years old or older\n* Screening score of \\>= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a scale.\n* Screening severity score of \\>= 55 on the PROMIS Scale v1.0 - Gastrointestinal Belly Pain scale.\n* Screening score of \\\u003C10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale\n* Adults with or without IBS are eligible; participants with IBS experiencing symptoms must meet the Rome IV criteria as determined by the Rome IV Diagnostic Questionnaire (R4DQ) IBS Module.\n* Able to maintain 80% compliance with daily questionnaires during the 2 week run-in period.\n* In good general health at the time of screening (Investigator discretion).\n* Able to read and understand English and provide informed consent.\n* Able to use a personal smartphone device and download Chloe by People Science.\n* Able to receive shipment of the product at an address within the United States.\n* Able to complete study assessments over the course of up to 19 weeks.\n\nExclusion Criteria:\n\n* Do not have a personal smartphone, internet access, or unwilling to download Chloe.\n* Concomitant Therapies:\n\nParticipants receiving any of the following treatments or therapies are excluded:\n\n* Any investigational therapies or treatments (pharmaceuticals, devices, supplements) within 30 days prior to randomization.\n* Ongoing psychological therapies specifically targeting gastrointestinal symptoms or functional disorders, including but not limited to GI-directed Cognitive Behavioral Therapy (CBT), GI hypnotherapy, or other therapies for Disorders of Gut-Brain Interaction (DGBI).\n* Treatment with Glucagon-like peptide-1 (GLP-1) agonists (e.g., semaglutide, tirzepatide) within the last 90 days prior to randomization, due to their known effects on gut motility and GI symptoms.\n* Current or recent (within the last 6 months) chemotherapy or immunotherapy for cancer treatment.\n* Current or planned use of any other digestive enzymes prescription or over-the-counter (OTC).\n* Chronic use (defined as daily use for \\>30 days within the last 90 days) of any medication known to have substantial gastrointestinal side effects (e.g., diarrhea, constipation, nausea) that, in the opinion of the Principal Investigator, may confound the assessment of study outcomes. This may include high-dose NSAIDs, opioids, prokinetics, bile acid binders, or certain antibiotics.\n* Variable use of probiotics, fiber supplements, laxatives, stool softeners, antidiarrheals (if taking) in the last 30 days. Variable use is defined as use of any probiotic, fiber supplement, laxative, stool softener, or antidiarrheal with a dose change greater than 50% in the last 30 days or initiation or discontinuation of a gut-active product in the last 30 days.\n\n  * Other Illnesses or Conditions:\n\nParticipants who have the following comorbidities or gastrointestinal illnesses are excluded:\n\n* Currently diagnosed with Alcohol Use Disorder and\u002For Substance Use Disorder\n* Currently pregnant, planning to become pregnant in the next 4 months, or breastfeeding\n* History of bariatric or other significant gastrointestinal surgery (e.g., small bowel resection, total colectomy) that has permanently altered GI anatomy or function. Standard appendectomy or cholecystectomy are generally permitted.\n\nAny underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes (e.g., Type I diabetes, Endometriosis, etc.).\n\n* Acute gastroenteritis within the past 4 weeks;\n* New diagnosis workup planned during study that may change diagnosis\u002F behavior\u002F medications (eg. colonoscopy prep or major bowel cleanse, upcoming GI consult that could affect eligibility).\n* Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.\n\n  * Self-reported known hypersensitivity or previous allergic reaction to corn and\u002For any previous reaction to digestive enzyme supplements (eg. Beano and Lactaid)\n  * Comorbid GI conditions: IBD - Ulcerative Colitis or Crohn's Disease, Microscopic Colitis, history of small bowel or colonic surgeries, Celiac disease, or Bile Acid Malabsorption (BAM).\n  * Screening score of ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale\n  * On a low FODMAP diet based on FODMAP FFQ results at Screening\n  * History of following a low FODMAP diet in the past 6 months (self-reported)\n  * Any history of following LFD (Low FODMAP Diet) with no response (i.e. failed LFD in past)\n  * Participants who are on or plan to initiate a major restrictive or elimination diet, or a structured weight-loss diet, during the study period.\n  * No planned changes in diet, lifestyle or medications for IBS during study period.\n  * Use of any antibiotics, antifungals, or antivirals within 2 weeks prior to randomization.\n  * Participants planning extended travel that would interfere with compliance or study procedures.\n  * Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.",{"count":79,"type":20},150,[53],"This study is a randomized, double-blind, placebo-controlled, within-individual crossover trial designed to assess the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend (FODZYME®) on gastrointestinal symptoms in adults with self-reported bloating.1\n\nThe study's rationale is based on the fact that fermentable carbohydrates (FODMAPs) are often poorly absorbed and can trigger symptoms like bloating and abdominal pain. While a Low FODMAP Diet (LFD) is clinically validated for symptom relief, it is restrictive. The enzyme blend is intended to offer a more flexible, enzyme-based solution by targeting and breaking down FODMAPs, such as fructan, GOS, and lactose, before they ferment in the colon.\n\nThe primary objective is to evaluate the product's impact on bloating symptoms, measured by the mean PROMIS scale Gastrointestinal Gas and Bloating score. Secondary and exploratory objectives include assessing the impact on overall gastrointestinal symptom severity (IBS-SSS), abdominal pain (PROMIS Belly Pain score), food-related quality of life (FR-QoL-29), and anxiety (GAD-7 scores). The study also aims to evaluate these effects across various Irritable Bowel Syndrome (IBS) subgroups (IBS-C, IBS-D, IBS-M). The trial is a consumer-driven, decentralized research study utilizing validated patient-reported outcome measures that can be completed in a home setting.",[83,84,85,27],"IBS (Irritable Bowel Syndrome)","Bloating","Abdominal Pain",[87,88,89,90],"bloating","gas","abdominal pain","IBS","2026-05-11",{"date":93,"type":35},"2026-05-15",{"date":95,"type":35},"2026-05-04",{"date":97,"type":20},"2026-10-26",{"name":99,"class":100},"Kiwi Health Inc","INDUSTRY",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":43},"100635970","the-effects-of-mango-on-gut-health-markers-100635970","NCT07559604","The Effects of Mango on Gut Health Markers","The Effects of Fresh Mango Consumption on Gut Permeability Markers and Short Chain Fatty Acid Production in Individuals With Prediabetes","Inclusion Criteria:\n\n* Participated in NCT06159543\n\nExclusion Criteria:\n\n* Did not participate in NCT06159543","40 Years","60 Years",{"count":111,"type":20},31,[53],"This is an ancillary study of NCT06159543, which was a clinical trial that examined the effect of a 12-week 1.5 cups daily mango crossover intervention on cardiometabolic outcomes in individuals with prediabetes, male and female, and 40-60 years of age. The goal of this ancillary study is to test the effect of the mango intervention on gut health markers in individuals with prediabetes. The main questions it aims to answer are:\n\n1. What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of gut permeability as measured by lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14)?\n2. What is the effect of 1.5 cups per day of fresh mango over 12 weeks on microbiome modulation as estimated by short chain fatty acids (SCFAs)?\n\nSecondarily:\n\n1. Is LBP a mediator of the relationship between systemic inflammation \\[as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)\\] and SCFAs?\n2. Is LBP a mediator of the relationship between insulin resistance \\[as determined by HOMA-IR\\] and SCFAs?\n3. Is sCD14 a mediator of the relationship between systemic inflammation \\[as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)\\] and SCFAs?\n4. Is sCD14 a mediator of the relationship between insulin resistance \\[as determined by HOMA-IR\\] and SCFAs?\n\nResearchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in LBP, sCD14, and SCFAs.\n\nAs noted, this is an ancillary study of NCT06159543. Fasting blood was collected at baseline, and at the end of each phase of NCT06159543. This blood will be used to analyze LBP, sCD14 and SCFAs. Fasting blood and insulin were analyzed in NCT06159543, and will used to calculate HOMA-IR in the ancillary study. C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1) will be analyzed NCT06159543.",[27,115,116,117],"LBP","Short Chain Fatty Acids","sCD14","2026-04-24",{"date":120,"type":35},"2026-04-30",{"date":122,"type":20},"2026-05",{"date":124,"type":20},"2027-12",{"name":126,"class":42},"Loma Linda University",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":135,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100377507","breastfeeding-and-gut-health-100377507","NCT04195425","Breastfeeding and Gut Health","Influence of Breastfeeding on Gut Health in Children","PENSINE","Inclusion Criteria:\n\nFor the mother:\n\n* Pregnant woman (\\>18 years old) followed at the Lille University Jeanne de Flandres Maternity\n* Woman who can speak, read and write in French\n* Single pregnancy\n* Informed consent\n* Living in the Lille area\n\nFor the father:\n\n* Men \\>18 years old\n* Informed consent\n\nExclusion Criteria:\n\nFor the mother:\n\n* Impossibility to participate to the study follow-up\n* Woman under guardianship or curatorship\n* Woman involved in another study inconsistent with biological samples collection\n\nFor the child after birth:\n\n* Prematurity \\\u003C37 weeks\n* Impossibility to participate to the study follow-up\n* Child under judicial protection measure\n* Child involved in another study inconsistent with biological samples collection","FEMALE",{"count":137,"type":20},500,"OBSERVATIONAL","The aim of the study is to evaluate the impact of early nutrition on gut health in children. A prospective cohort of newborns will be recruited at birth and followed up to 4 years of age. Information on parent's nutritional habits and life style, breastfeeding duration and child's complementary feeding, will be collected. Cord blood cells and stools will be collected at birth, 6 months, 2 years and 4 years of age for implementing a biological collection. Gut health will be evaluated in children during the first four years of life based on fecal secretory immunoglobulin A (SIgA) and presence of digestive symptoms. Precise data on breastfeeding practices and their short- and medium-term effects on the health of the child, in particular and in an innovative way on gut health, will be obtained.",[27],[142,143,144],"breastfeeding","early nutrition","intestinal microbiota","2026-04-01",{"date":147,"type":35},"2026-04-07",{"date":149,"type":35},"2020-12-17",{"date":151,"type":20},"2031-06",{"name":153,"class":42},"University Hospital, Lille",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":15,"sex":16,"minAge":162,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":43},"100600128","colon-delivered-riboflavin-and-gut-microbiota-composition-100600128","NCT07093463","Colon-delivered Riboflavin and Gut Microbiota Composition","The Benefit of Colon-delivered Riboflavin (Riboflavin-cd) vs. Conventional Riboflavin on Gut Microbiota Composition and Metabolic Output in Healthy Aging Subjects - a Pilot Proof of Concept Study","CONCOL","Inclusion Criteria:\n\n1. Individuals providing written informed consent for participation in the study and data processing\n2. Female and males between 50 and 70 years of age\n3. For females only: Menopausal as marked by at least 1 year since the last menstrual bleeding\n4. Individuals with a BMI between 18.5 - 29.9 Kg\u002Fm2\n5. Individuals with stable body weight (≤5% change) over the past 3 months prior to V1\n6. Individuals with self-reported moderate bowel complaints in at least last 3 months prior to V1\n7. Individuals with GSRS score suggestive of moderate bowel complaints, as assessed at V1, for the average condition over the 4 last weeks (all GSRS items have to be answered at V1): • indigestion score 3-5 or constipation score 3-5 or diarrhoea score 3-5\n8. Individuals with a general good health, as determined by questioning, clinical examination and vital signs (blood pressure, pulse rate) by the investigator at V1\n9. Individuals willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, synbiotic or fibre-rich supplements during the entire study duration\n10. Individuals willing to maintain current level of physical activity throughout the entire study duration\n11. If individuals are taking chronic medications (e.g., antihypertensive medications), they must be willing and expected to maintain the same dosage throughout the study\n\nExclusion Criteria:\n\n1. Individuals who are hypersensitive\u002Fintolerant to any of the components of the Investigational product or the standardised diet addition (inulin)\n2. Individuals who have taken systemic antibiotics within the previous 3 months prior to Baseline (V2) or are expected to be taking any during the study\n3. Individuals who consumed microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements within 4 weeks prior to the baseline (V2)\n4. Individuals who are currently regularly using systemic steroids, proton pump inhibitors, H2 blocker, antacids (however, sporadic use during the study if needed is allowed, but not within 8 hours before each visit), metformin if started less than 6 months prior to V1, or immunosuppressant medication.\n5. Individuals who have a history of drug abuse in the previous 5 years and\u002For alcohol abuse at the time of enrolment (\\>11 units\u002Fweek for women; \\>17 units\u002Fweek for men; unit: approx. 125 mL of wine or similar \u002F approx. 30 mL of spirits\n\n   \u002F approx. 280 mL beer or similar); Is currently in treatment for alcohol\u002Fsubstance abuse; Has been diagnosed with alcohol\u002Fsubstance abuse disorder)\n6. Individuals who are a smoker or vaper\n7. Individuals who are vegetarian or vegan\n8. Individuals who have made any major dietary changes in the past 3 months prior to Baseline (V2)\n9. Individuals who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.\n10. Individuals who have a currently present active eating disorder\n11. Individuals with self-reported food allergy \u002F intolerance (e.g., lactose, gluten, fructose), as determined by the study investigator\n12. Clinical significance for any of screening laboratory test results from the blood draw at V1, as per investigator's judgement\n13. Individuals with a self-reported fibre-rich regular diet, as per investigator's judgement\n14. Individuals who have a (self-reported) gastrointestinal disorder\u002Fdisease (e.g., chronic\u002Frecurrent diarrhoea, inflammatory bowel disorder, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, bile acid malabsorption) or previous gastrointestinal surgery (such as bariatric surgery, colon specific surgical interventions etc.), which in the opinion of the investigator would impact the study outcomes\n15. Individuals with GSRS assessed at V1 for the average condition over the 4 last weeks prior to V1 for any score (abdominal pain, reflux score, indigestion, constipation, diarrhoea) \\>5 (all GSRS items have to be answered at V1)\n16. Individuals who have severe or uncontrolled conditions such as type 2 diabetes (FBG ≥ 150 mg\u002Fdl from blood draw at V1), psychiatric disorder, respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes\n17. Individuals who have a history of any gastrointestinal cancer\n18. Individuals who are severely immunocompromised\n19. Individuals with alarm features in the past 3 months prior to V1 such as unintentional weight loss (≤5% change), fever, anorectal problems, blood in stool, vomiting\n20. Individuals who, in the opinion of the investigator are considered to be poor attendees or unlikely for any reason to be able to comply with the study requirements\n21. If Individuals have been in a recent experimental study, this must have been completed not less than 30 days prior to this study","50 Years","70 Years",{"count":165,"type":20},90,[53],"Recent studies suggest B-vitamins such as riboflavin to possess prebiotic-like effects. However, there is still a lack of understanding of the exact host health benefits vs. conventional systemically available vitamin forms. The present study explores the benefit of colon-delivered vitamin B2 vs. conventional vitamin B2 in comparison to placebo in an aging population on gut microbiota and metabolic activity as well as gut health.",[169,27],"Microbiome Dysbiosis",[171,172,173,174],"elderly","microbiome","colon delivered b-vitamins","riboflavin","2026-03-17",{"date":177,"type":35},"2026-03-19",{"date":179,"type":35},"2025-07-18",{"date":181,"type":20},"2026-09",{"name":183,"class":100},"dsm-firmenich Switzerland AG",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":43},"100625358","an-8-week-study-evaluating-gut-and-digestive-health-after-use-of-a-dietary-supplement-system-100625358","NCT07421596","An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System","An Eight-week Clinical Study for the Measurement of Gut and Digestive Health Parameters Before and After the Use of a Dietary Supplement System","Inclusion Criteria:\n\n* 1\\. Male or female adults aged 18 to 80 years (considering 50% men and 50% women, even breakdowns in age groups 18-30, 31-60, 61-80 years, and 12-15% African American required) at the time of screening.\n\n  2\\. Willing and able to provide written informed consent before participation in any study-related procedures.\n\n  3\\. Willing and able to comply with all study procedures, including clinic visits, completion of questionnaires, and stool sample collection at predetermined time points.\n\n  4\\. Willing to collect and provide stool samples, either in-clinic or at home as instructed.\n\n  5\\. Willing to abstain from alcohol consumption (including beer, wine, and spirits) for the duration of the study.\n\n  6\\. Proficient in written and spoken English. 7. Willing to provide a valid email address and mobile phone number and able to complete electronic forms and questionnaires using a smartphone.\n\n  8\\. Able and willing to travel to the Research Institute for in-clinic visits and stool sample collection as scheduled.\n\n  9\\. No known food allergies, based on subject self-report. 10. Willing to maintain usual diet and lifestyle habits, except as required by the study protocol.\n\n  11\\. Subjects with self-reported gastrointestinal symptoms, defined as a baseline Gastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 subjects) and score ≤ 3 (5 subjects).\n\nExclusion Criteria:\n\n* 1\\. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products.\n\n  2\\. Presence or history of any medical condition that may interfere with study participation or outcome interpretation, including but not limited to:\n  * Malabsorption disorders\n  * Chronic gastrointestinal diseases\n  * Severe depression\n  * Clinically significant cardiovascular disease within the past 3 months 3. Pregnant, breastfeeding, or planning to become pregnant during the study period, based on subject self-report.\n\n    4\\. Having a pregnant partner or a partner who is planning to become pregnant during the study period and is unwilling or unable to use an acceptable method of contraception.\n\n    5\\. History of any cancer within the past 5 years. 6. Active or occasional smoking. 7. Current use of probiotics, unless willing to discontinue use at least 4 weeks prior to study enrollment.\n\n    8\\. History of weight loss surgery or any type of bowel surgery, including resection or colectomy.\n\n    9\\. Any active infection within the past 3 months requiring antibiotics, antiviral medication, or hospitalization.\n\n    10\\. Use of immunosuppressive medications within the past 12 months, including systemic corticosteroids or biologic agents.\n\n    11\\. History of seizure disorder or use of seizure medication within the past 4 weeks.\n\n    12\\. History of HIV infection or solid organ transplantation. 13. Use of medications for chronic gastrointestinal or digestive conditions, including but not limited to:\n  * Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®)\n  * Laxatives or gastrointestinal motility agents\n  * Medications for irritable bowel syndrome (IBS), Crohn's disease, or history of hospitalized diverticulitis 14. Any other condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation or compromise subject safety or study integrity.","80 Years",{"count":193,"type":20},50,[53],"This clinical research study is being conducted to evaluate gut and digestive health before and after the use of a dietary supplement system over an eight-week period.\n\nGut and digestive health play an important role in overall health, including digestion, nutrient absorption, immune function, and metabolic balance. Changes in gut microbiota, inflammation, and intestinal barrier function may contribute to digestive symptoms such as bloating, discomfort, altered bowel habits, and reduced well-being.\n\nIn this study, adult men and women with self-reported gastrointestinal symptoms will consume a dietary supplement system daily for eight weeks. The study will measure changes in gut and digestive health using objective stool-based laboratory biomarkers and validated symptom questionnaires.\n\nStool samples will be collected at baseline and at the end of the study to evaluate markers related to microbial diversity, inflammation, immune activity, digestive function, and intestinal barrier integrity. Participants will also complete questionnaires throughout the study to assess gastrointestinal symptoms and subjective digestive health and well-being.\n\nThe study will also monitor the safety and tolerability of the dietary supplement system during the study period.",[58,197,27],"Digestive Health",[199,200,201,202],"Stool biomarkers","Probiotics","Subjective digestive health","Gut Zoomer stool test","2026-02-22",{"date":205,"type":35},"2026-02-24",{"date":207,"type":20},"2026-02-05",{"date":209,"type":20},"2026-04-21",{"name":211,"class":212},"SF Research Institute, Inc.","NETWORK",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":162,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":43},"100622795","impact-of-weizmannia-bacillus-coagulans-jbi-yz63-on-gut-health-and-fecal-microbiome-changes-100622795","NCT07388264","Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes","Examining the Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes","WIZ","Inclusion Criteria Ages of 18 - 50 years Average daily bloating score \\>5 on question 3 of the Modified daily Abdominal, Gas, and Bloating Questionnaire and\u002For bloating for \\>5 days during the past 14 days Body mass index (BMI) 18.5 - 29.9 kg\u002Fm2 (Inclusive) (Individuals \\>29.9 kg\u002Fm2, but \\\u003C25% fat for men and \\\u003C30% fat for women will be accepted into the study. The cohort average of body mass index will not exceed 29.9 kg\u002Fm2) Weight stable for the past three months (defined as less than a 5% variation in body mass over this time) Determined to be healthy through completion of a health history questionnaire Subject agrees to maintain their existing dietary patterns throughout the study period and to report to study investigators any changes particularly as they relate to probiotic-containing or fermented foods Subject agrees to refrain from alcohol, caffeine, and strenuous exercise for 24 hours prior to each test day.\n\nMinimum baseline physical activity level (defined as at least 30 minutes of moderate intensity exercise at least 4 days per week for the past 3 months) Subject is willing and able to comply with the study protocol. Study participant is not currently enrolled in another clinical trial that involves the administration of some investigative agent Subject has given voluntary, written, informed consent to participate in the study.\n\nExclusion Criteria Positive medical history and\u002For is currently being treated for some form of heart disease, cardiovascular disease Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals Has liver disease or some form of clinically diagnosed hepatic impairment Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose \\> 126 mg\u002FdL) Diagnosed with or is being treated for some form of thyroid disease Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year Diagnosed with some form of immune disorder (i.e., HIV\u002FAIDS) History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).\n\nParticipant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) Participant has been treated for a gastrointestinal related disorder, complication, or disorder within the past 30 days Positive medical history for any neurological condition or neurological disease Diagnosed with or being treated for any endocrinological disorder or currently used any form of hormone replacement (prescribed\u002Fdoctor ordered or not) Women with a history of hormone-related conditions such as endometriosis, fibroids, polycystic ovary syndrome Currently prescribed for the first time statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months Currently prescribed for the first time hypertension medication (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.) within the past 6 months or has had their dosage or medication changed within the past 6 months Current antibiotic use or other prescription or over-the-counter medications that may impact study outcomes Have a known sensitivity or allergy to any of the study products Blood donation in past 60 days Current smoker (average of \\> 1 pack per week within the past 3 months) or has quit within the past six months. This includes all forms of nicotine They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study Competitive athletes will be excluded History of alcohol or substance abuse in the 12 months prior to screening Current use of anabolic steroids (medically prescribed or otherwise) Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol Report taking a probiotic or other dietary supplement know to impact digestion or gut function in the past 30 days Recent history (\\\u003C3 months) of exercise training or weight loss (\\> 5%) Currently following a ketogenic or low carbohydrate diet within the past 30 days.\n\nWomen who are pregnant, planning to become pregnant, or lactating currently or within the past six months Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data",{"count":222,"type":20},30,[53],"This study will evaluate the effects of supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 on gastrointestinal health in healthy, physically active adults. The primary objective is to determine whether daily intake of this probiotic strain improves symptoms of constipation and related gastrointestinal function compared with placebo.\n\nApproximately 30 healthy men and women aged 18 to 50 years will be enrolled in a randomized, double-blind, placebo-controlled, crossover trial. Participants will complete two 4-week supplementation periods, one with Weizmannia (Bacillus) coagulans JBI-YZ6.3 and one with placebo, separated by a 4-week washout period. The total duration of participation will be approximately 13 to 14 weeks, including screening and testing visits.\n\nGastrointestinal symptoms will be assessed at baseline and after each supplementation period using validated questionnaires, with particular focus on the constipation domain of the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes will include additional gastrointestinal symptom domains and markers of perceived gut comfort and function.\n\nThis study is designed to determine whether supplementation with Weizmannia (Bacillus) coagulans JBI-YZ6.3 produces clinically meaningful improvements in gastrointestinal symptoms in physically active adults compared with placebo.",[58,226,27,227],"Constipation","Gastrointestinal Function","2026-01-28",{"date":207,"type":35},{"date":231,"type":35},"2025-06-15",{"date":233,"type":20},"2026-06-15",{"name":235,"class":42},"Lindenwood University",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":15,"sex":16,"minAge":242,"maxAge":163,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":43},"100621542","a-study-to-evaluate-the-effects-of-a-butyrate-polyphenol-formulation-on-gut-health-and-associated-symptoms-100621542","NCT07371975","A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms","Inclusion Criteria:\n\n1. Male or female, age 25-70 years\n2. Body mass index 18.5-34.9 kg\u002Fm2\n3. A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is \\\u003C 20 (identification of minimal or mild), may be included at the discretion of the PI\u002FSub-I\n4. Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)\n5. Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI\u002FSub-I)\n6. Weight stable for the past six months (±6 lbs.)\n7. Willing and able to give written informed consent\n8. Ability to communicate and read in English\n9. Ability to comply with study requirements\n\nExclusion Criteria:\n\n1. Currently participating in another clinical research study\n2. Pregnant, planning pregnancy, or breastfeeding\n3. Unable to swallow capsules, tablets, or softgels\n4. Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.\n5. Typically goes longer than 3 days without a bowel movement\n6. Current diagnosis of cardiovascular disease, history of an abnormal electrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except for non-melanoma skin cancer) within the past 5 years\n7. Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.\n8. Planning to undergo a major medical procedure or surgical event within the next 30 days\n9. Currently being treated for any infectious disease\n10. Currently consuming more than 6 standard alcoholic drinks per week for women and 10 drinks per week for men (a standard alcoholic drink is defined as one bottle\u002Fcan of beer, one glass of wine, or one ounce of hard liquor)\n11. Smoking or use of nicotine products daily within 30 days prior to screening\n12. Using substances of abuse or recreational drugs\u002Fsubstances, including tetrahydrocannabinol (THC), within the past 14 days\n13. History of intolerance or allergic reaction to product ingredients, including butyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamon extract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)\n14. Having donated blood or received a blood\u002Fplasma transfusion within 30 days before baseline\n15. History of a major change in dietary habits within the past 1 month\n16. Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation\n17. Currently taking any laxatives on a daily basis\n18. Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.\n19. On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.\n20. History of oral or IV antibiotic use within the past 3 months prior to Baseline\n21. Not willing to refrain from taking any over-the-counter medications or supplements for gastrointestinal concerns or discomfort (except if on a stable dose for \\> 3 months before Screening and unlikely to change) unless in the judgment of the PI\u002FSub-I\n22. Current or previous history of medically diagnosed and treated gastrointestinal disease, including gallbladder problems, gallstones, biliary obstruction, inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiac disease, or gastrointestinal cancer\n23. Currently diagnosed with and\u002For being treated for Irritable Bowel Syndrome (IBS)\n24. Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month\n25. Currently experiencing or previously having a parasitic infection within the past 3 months\n26. Currently experiencing or having a history of severe endometriosis\n27. History of gastrointestinal surgery, which might influence gastrointestinal function\n28. History or presence of a clinically significant diagnosis or circumstance that, in the judgment of the Study Investigator\u002FSub-I, would interfere with the interpretation of the study results and preclude participation in the study -","25 Years",{"count":244,"type":20},124,[53],"The purpose of the study is to evaluate the efficacy of a butyrate\u002Fpolyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.",[27],[249,250,251,84,252,226],"Gastrointestinal discomfort","Abdominal pain","Gas","Diarrhea","2026-01-27",{"date":255,"type":35},"2026-01-29",{"date":257,"type":35},"2025-10-16",{"date":259,"type":20},"2026-07-30",{"name":261,"class":100},"Supplement Formulators, Inc.",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":15,"sex":135,"minAge":17,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":43},"100601378","the-effect-cranberry-based-products-on-the-female-microbiome-100601378","NCT07109713","The Effect Cranberry-Based Products on the Female Microbiome","A Randomized, Parallel, Controlled Trial Investigating the Effects a Cranberry-Based Products on the Female Microbiome","Inclusion Criteria:\n\n* Pre-menopausal female,\n* 18 - 45 years of age (inclusive) at visit 1.\n* History of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior to visit 1. Participants that are using contraceptives (IUD, patch, or pills) must be on a stable dose, defined as no change in medication regimen, within 90 days of visit 1 (or within 6 months of visit 1 for copper IUD users) and no plans to change hormonal contraceptive use during the study.\n* BMI ≥18.5 to \\\u003C30.0 kg\u002Fm2 at visit 1.\n* Willing to adhere to all study procedures, including lifestyle considerations (see section 6.2), and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.\n\nExclusion Criteria:\n\nWomen's health related criteria\n\n•Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.\n\nGeneral health related criteria\n\n* Participant has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).\n* History or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and\u002For affect study outcomes, in the judgment of the Investigator.\n* Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit •Stable use of hypertension medication is allowed (defined as no change in medication regimen ≤ 90 d of visit 1).\n* Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment has been completed at least 5 days prior to testing.\n* History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.\n* History of any major trauma or major surgical event within 2 months of visit 1.\n* Subject has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.\n* Underwent an endoscopy or colonoscopy preparation within 3 months prior to visit 1.\n\nExclusionary products related criteria\n\n* Recent history of (within 12 months of screening; visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \\>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).\n* Use of tobacco\u002Fnicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.\n* Habitual users (i.e., daily or almost daily) of marijuana and hemp products, including CBD products, and willing to abstain from use throughout the study period (topical creams\u002Flotions are allowed). Occasional use (e.g., couple times a month) within 12 months of visit 1 is allowed but requires at least a 14 d washout prior to visit 1 and the participant must be willing to refrain from use during the study.\n* Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days of visit 1. This exclusion criterion does not include hormonal contraceptives.\n* Exposed to any non-registered drug product within 30 days prior to visit 1.\n* Antibiotic use within 30 d of visit 1 and throughout the study period.\n* Steroid use within 30 d of visit 1 and throughout the study period.\n* Current habitual user (≥ 3 days\u002Fweek ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDs, acetaminophen, etc.).\n* Use of medications (over-the-counter or prescription) and\u002For dietary supplements, known to influence GI function, including but not limited to, pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and\u002For anti-spasmodic within 30 d of visit 1 and throughout the study period. Standard multivitamin and mineral supplements are allowed.\n* Willing to avoid consuming probiotics or fermented foods within 14 d of visit 1 and throughout the study period.\n* Willing to avoid consuming high-polyphenol foods and supplements \\[e.g., dark colored and polyphenol-rich fruits (berries, grapes, pomegranates, cherries, grapefruit, black currant, plum) and their processed food\u002Fjuice and related supplement products (e.g. grape seed extract, green tea extract); red wine; dark chocolate; cranberry extract supplements\\] throughout the study period.\n\nGeneral safety related criteria\n\n* Known sensitivity, intolerability, or allergy to any of the study products or their excipients.\n* Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk","45 Years",{"count":271,"type":20},60,[53],"The overall objective of this clinical trial is to compare the effects of a cranberry-based product to a placebo-control product on vaginal and GI microbiome outcomes and associated participant reported outcomes in generally healthy pre-menopausal women",[275,26,27],"Vaginal Microbiome",[277,278,279,280],"vaginal microbiome","gut microbiome","cranberry","polyphenols","2025-08-11",{"date":283,"type":35},"2025-08-14",{"date":285,"type":35},"2025-08-05",{"date":287,"type":20},"2025-12-20",{"name":289,"class":100},"Ocean Spray Cranberries, Inc.",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":43},"100595708","effects-of-effera-human-lactoferrin-at-one-dose-compared-to-placebo-on-gut-permeability-100595708","NCT07035964","Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability","Randomized, Double-Blind, Placebo-Controlled, Parallel Study on the Effects of Effera Human Lactoferrin on Gastrointestinal Permeability","Inclusion Criteria:\n\n1. Male or premenopausal female, 18 - 40 years of age, inclusive\n2. BMI ≥ 18.5 to \\\u003C 40.0 kg\u002Fm2\n3. Abdominal adiposity defined by a waist circumference \\>40\" in men or \\>35\" in women measured at Visit 1.\n4. Reports at least mild GI symptoms from the 7d GI Symptom Questionnaire collected at visit\n\n2\\. Mild GI symptoms will be defined as a combined weekly total score of gas\u002Fflatulence, abdominal distention\u002Fbloating, borborygmus\u002Fstomach rumbling, or burping symptoms ≥ 3.\n\n5\\. Non-user or former user (daily use; cessation ≥ 12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.\n\n6\\. Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD\u002FTHC products, and willing to abstain from use throughout the study period (topical creams\u002Flotions are allowed).\n\n7\\. Willing to use personal smart phone with operating system (Android version 8.0 or newer; iOS version 15.5 or newer) capable of downloading the Cronometer app for diet records.\n\n8\\. Willing to adhere to all study procedures, including lifestyle considerations ,and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.\n\nExclusion Criteria:\n\n1. Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).\n2. Recent (≤ 3 months of visit 1) endoscopy or colonoscopy preparation.\n3. Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for participants with abnormal laboratory test results.\n4. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1. Stable use of hypertension medication is allowed (defined as no change in medication regimen within the 90 days prior to Visit 1).\n5. Uncontrolled and\u002For clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and\u002For anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.\n6. Unstable use (change in dose) of any prescription medications ≤ 90 d of visit 1, except for medications used PRN (e.g., asthma inhalers, non-drowsy seasonal allergy medications, etc.).\n7. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.\n8. Major trauma or any surgical event within 3 months of visit 1.\n9. Currently scheduled, or planning to schedule, an elective surgical procedure during the study.\n10. Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled once all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1. If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits.\n11. Diagnosis of tuberculosis of hepatitis within 1 year prior to study.\n12. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan\u002Fvegetarian) at the discretion of the Clinical Investigator.\n13. Weight loss or gain \\>4.5 kg in the 3 months prior to visit 1.\n14. Currently or planning to be on a weight loss regimen during the study.\n15. Recent history (≤ 12 months visit 1) of alcohol or substance abuse. Alcohol abuse is defined as \\>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 11⁄2 oz distilled spirits).\n16. Antibiotic use within 3 months of visit 1 and throughout the study period.\n17. Recent use of oral or injectable steroids, or topical or inhaled steroids (≥ 1500 μg\u002Fd), ≤ 90 dof visit 1.\n18. Regular use (≥ 3 days\u002Fweek ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDS) and throughout the study period.\n19. Use of medications (over-the-counter or prescription) and\u002For dietary supplements known to influence GI function, including but not limited to: pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and\u002For anti-spasmodic within 2 weeks of visit 1 and throughout the study period.\n20. Recent use of dietary supplements containing bovine lactoferrin or iron in excess of the RDA (within 60 d of Visit 1). Standard multivitamin and mineral supplements are allowed.\n21. Exposure to any non-registered drug product within 1 month of visit 1 and throughout the study period.\n22. Pre-menopausal females with an irregular menstrual cycle (regular cycle defined as 21 to 35 days in length for the last 3 months prior to visit 1).\n23. Female who is diagnosed with Premenstrual Dysphoric Disorder (PMDD).\n24. Female who reports only experiencing GI symptoms around the time of menses.\n25. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Women who become pregnant during the study will be discontinued.\n26. Female who is unwilling to adhere to medically-recognized forms of birth control (e.g., hormonal and non-hormonal contraceptives, barrier methods, abstinence, etc).\n27. Female who is unwilling to wear a tampon during the collection of urine samples when these collections occur during the time of menstruation.\n28. Known sensitivity, intolerability, or allergy to any of the study products, study foods, or their excipients.\n29. Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, and comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.",{"count":298,"type":20},46,[53],"The purpose of this study is to evaluate the impact of 28-day supplementation with effera human lactoferrin, compared to a placebo control product on indicators of gut barrier health in males and females",[302,27],"Gut Permeability","2025-06-16",{"date":305,"type":35},"2025-06-25",{"date":307,"type":35},"2025-06-04",{"date":309,"type":20},"2025-08-30",{"name":311,"class":100},"Helaina Inc.",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":269,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":323,"conditions":324,"keywords":333,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":43},"100577217","a-randomized-double-blind-study-to-assess-the-effect-of-a-postbiotic-on-oxidative-stress-and-exercise-performance-100577217","NCT06795425","A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance","A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study, to Assess the Effect of a Novel Postbiotic Blend on Exercise Induced Oxidative Stress Markers and Exercise Performance","PBE","INCLUSION CRITERIA\n\nTo be eligible for inclusion, the participant must fulfill all of the following criteria:\n\n1. Male or female participants between 18 - 45 years of age\n2. Signed informed consent.\n3. Health, which is defined as currently not being treated for an active cardiac, pulmonary, metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal, psychiatric, or reproductive disease or disorder. With research team and principal investigator discretion, some ongoing treatments will be permitted if a determination is made that the treatment will not increase risk of study participation and the treatment or illness itself will not confound with desired study outcomes.\n4. Physically active, which is defined as performing aerobic or resistance-based physical exercise between 2 and 5 times per week at a rating of perceived intensity (RPE) of 4 or greater (out of 10)\n5. Body mass index values will range from \\>18.5 to \\\u003C 29.9 kg\u002Fm2 (Inclusive)41 (Weir and Jan 2024).\n6. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures.\n\nEXCLUSION CRITERIA\n\nParticipants will be excluded from the study if they meet any of the following criteria:\n\n1. Body mass index \\\u003C18.5 to \\\u003C29.9 kg\u002Fm2 (Inclusive)\n2. Use of antibiotics or probiotics in the previous 3 months\n3. Positive medical history and\u002For is currently being treated for some form of heart or cardiovascular, neurological impairment, disease or condition, immune disorder or disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver disease or other diagnosed hepatic impairment.\n4. Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose \\> 126 mg\u002FdL)\n5. Diagnosed with major affective disorder or other significant psychiatric disorder or disturbance that required hospitalization or home intervention in the prior year.\n6. History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).\n7. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, bile acid malabsorption, H.pylori infection, small intestine bacterial overgrowth (SIBO), celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)\n8. Recently prescribed or change in dosage (within the past 6 months) of statin drug (i.e., Lipitor, Livalo, Crestor, Zocor, etc.), hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.), or psychiatric medications.\n9. Consumption (any dose or amount) of any nicotine-containing product (cigarette, cigar, vaping, etc.)\n10. Participants who are lactating, pregnant or planning to become pregnant.\n11. History of alcohol or substance abuse in the 12 months prior to screening\n12. Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol.\n13. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.\n14. Extensive travel (\\>1 month) that will disrupt original outline of the study protocol.\n15. Participant is consuming a biotic product (pre-, pro-, syn-, or post-) or alters their diet resulting in a change in the amount of prebiotic, probiotic, or fermented foods that are consumed while in the study protocol.",{"count":321,"type":20},80,[53],"This is a prospective, randomized, placebo controlled, double-blind study to assess the effects of a postbiotic blend on exercise induced oxidative stress markers and exercise performance in healthy adult.",[325,326,327,328,329,27,330,331,332],"Oxidative Stress","Healthy","Exercise-induced Muscle Damage","Exercise-induced Muscle Soreness","Immune Function","Microbiome Analysis","Exercise Performance","Exercise Metabolism",[334,335,336,337,338,339,340,278,341,342,343,344,345,346,347,348,349,350,351],"oxidative stress","antioxidants","postbiotics","ergogenic aid","exercise performance","muscle damage","recovery","immune function","sleep quality","anxiety","recreationally active","inflammation","endurance training","fecal microbiota","nutritional supplement","aerobic exercise","biomarkers","clinical trial","2025-01-21",{"date":354,"type":35},"2025-01-28",{"date":356,"type":20},"2025-02-01",{"date":358,"type":20},"2026-01-01",{"name":235,"class":42},{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"100566710","a-study-to-assess-the-effect-of-the-natural-orange-extract-in-individuals-with-gastrointestinal-discomfort-100566710","NCT06658717","A Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort","A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort","Inclusion Criteria:\n\n1. Individuals willing to give written informed consent form voluntarily to participate in the study\n2. Healthy males and females of age between 18-65 years.\n3. Individuals with a Body Mass Index (BMI) between 18.5-29.9 kg\u002Fm2 (both values included).\n4. Individuals with a history of GI discomfort, associated with changes in the frequency and form of stools for the last 3 months, with symptom onset at least 6 months.\n5. Individuals with complaints of loose or watery stools, occurring in more than 25% of stools for the last 3 months.\n6. Individuals with consistent and stable body weight in the last 3 months prior to screening (less than 5% self-reported change).\n7. Individuals with a baseline score of less than or equal to 55 for the digestive domain score of the Gastrointestinal Quality of Life Index (GIQLI).\n8. Individuals with Fasting Blood Glucose (FBG) less than equal to 125 mg\u002Fdl.\n9. Individuals with systolic blood pressure (SBP) less than 140 and\u002For diastolic blood pressure (DBP) less than 90 mm Hg.\n10. Individuals willing to avoid consumption of citrus-based products during the entire study duration.\n11. Individuals willing to follow all the study procedures and follow-up visits as per protocol.\n\nExclusion Criteria:\n\n1. Individuals diagnosed with diabetes mellitus and are on active medication.\n2. Individuals diagnosed with hypertension and are on active medication.\n3. Individuals with thyroid dysfunction as assessed by Thyroid Stimulating Hormone (TSH) less than or equal to 0.4 or more than or equal to 5.0 mIU\u002FL will be excluded.\n4. Individuals with a history and\u002For presence of acute or chronic significant GI disease or digestion\u002Fabsorption disorders (e.g., Irritable bowel syndrome, inflammatory bowel disease, infectious diarrhea, coeliac disease, Clostridium difficile colitis, malabsorption, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc).\n5. Individuals with a history of autoimmune disorders.\n6. Individuals with major gastric, hepatic, biliary, pancreatic, or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, haemorrhoidectomy, or polypectomy allowed as long as occurred more than 3 months prior to screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred more than 3 months prior to screening).\n7. Any other relevant serious organ or systemic diseases (e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc).\n8. Individuals with a history of malignancy within last five years.\n9. Use of immunosuppressive drugs within 3 months prior to the screening.\n10. Use of oral corticosteroids within 1 month prior to the screening.\n11. Excessive alcohol drinking (For men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more on any day or 8 or more drinks per week). One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer.\n12. Individuals with a history of\u002Fknown allergies to citrus fruits or citrus-based products.\n13. Individuals taking any antibiotics in the past 4 weeks and during the study.\n14. Individuals who are on regular intake of laxatives in the past 1 month prior to the screening.\n15. Individuals taking any dietary supplements, and medication for any gastrointestinal or metabolic disease (peptic ulcer, IBS, type-II diabetes, atherosclerosis, etc.)\n16. Individuals taking any hormones for any gastrointestinal or metabolic disease within 3 months prior to screening.\n17. Individuals taking any probiotics, prebiotics, post-biotics or synbiotics within 3 months prior to the screening.\n18. History of smoking or currently smoking.\n19. Individuals with gluten and\u002For lactose intolerance.\n20. Females who are pregnant\u002Flactating or planning to be pregnant.\n21. Individuals who have participated in another clinical study(ies) with an IP within 90 days before screening, or who plan to participate in another study during the study period.\n22. Any other conditions, which in the opinion of the investigator may jeopardize the study.","65 Years",{"count":369,"type":20},64,[53],"A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort",[27],"2024-10-23",{"date":375,"type":35},"2024-10-26",{"date":377,"type":20},"2024-10-15",{"date":379,"type":20},"2025-01-30",{"name":381,"class":100},"Vedic Lifesciences Pvt. Ltd.",3]