[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"dsm-firmenich Switzerland AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":155},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,77,106,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100629206","effect-of-daily-humiome-post-lb-intake-on-wellbeing-in-older-individuals-with-moderate-stress-levels-100629206",false,"NCT07471659","Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels","A Randomised, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy of Three Months Daily Ingestion of Humiome® Post LB on Wellbeing in 50 - 75 Year-old Adults in France","PostWelLB","INCLUSION CRITERIA:\n\n* Men and women aged between 50 and 75 years old (limits included),\n* Body mass index (BMI) ≥ 18.5 and \\\u003C 30 kg\u002Fm²\n* Presenting a level of psychological stress characterized by a PSS-10 score ≥ 14 and ≤ 26,\n* For women: not at risk of pregnancy (as per definitions of Appendix 13) Participants currently of childbearing potential, using an effective method of contraception.\n* Menopausal without hormone replacement therapy (estrogenic replacement therapy stopped since more than 3 months can be included)\n* Good general and mental health according to the opinion of the investigator: No relevant abnormalities from medical history nor from the medical consultation\n* Agreeing to maintain lifestyle habits during the study (same dietary and physical activity habits)\n* Able and willing to participate to the trial by complying with the protocol procedures as evidenced by a dated and signed ICF\n* Affiliated with a social security scheme,\n* With access to a health-care provider, who can be contacted by the CRO, and who reside in areas with available emergency health services,\n* Agreeing to be registered in the national database of subjects participating in clinical research,\n* Having a smartphone or personal computer compatible with the eConsult and ePRO applications.\n\nEXCLUSION CRITERIA:\n\n* Suffering from a metabolic disorder such as treated or untreated diabetes,\n* Suffering from thyroid dysfunction, high blood pressure or other metabolic disorders treated for less than 6 months and\u002For non-stabilized,\n* Suffering from a severe chronic disease: cancer, HIV, renal failure, hepatic or biliary disorders ongoing (except for cholecystectomy since more than two years and asymptomatic), chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble (except for mild asthma under treatment),\n* Suffering from GI disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease, Chron's disease, etc.),\n* With a known food allergy or intolerance or hypersensitivity to any of the trial products' ingredients,\n* Women who are pregnant or lactating or intend on becoming pregnant within the following six months,\n* Having a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disturbance, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric\u002Fneurologic condition that could interfere with the interpretation of the study results in the opinion of the investigator,\n* Having recently experienced or currently experiencing a significant stress as per investigator's judgment (e.g. grieving, divorce, moving, etc.),\n* Having a condition and\u002For receiving a treatment that may cause immunosuppression (e.g.: under immunomodulating treatment for HIV infection, allograft, auto-immune disease or cancer, etc.)\n* Under treatment or dietary supplement which could significantly affect parameter(s) followed during the trial according to the investigator or stopped less than one month prior to V1,\n* Under treatment with one or more of the following treatments stopped less than one month prior to V1:\n* psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and\u002For narcotics having an effect on stress, sleep aid medications, supplements, and\u002For products, including antihistamines, acid-blocking medication (e.g., proton pump inhibitor, H2 blocker),\n* Under treatment with an effect on the microbiome such as antibiotics stopped less than one month prior to V1,\n* Having a lifestyle deemed incompatible with the trial according to the Investigator as described below:\n* Practicing a high-level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded),\n* Regularly consuming more than 2 standard drinks of alcohol daily or 14 weekly or not agreeing to keep alcohol consumption habits unchanged throughout the study,\n* With a significant change in dietary or physical activity habits in the 3 months prior to randomisation (no hyper or hypocaloric diet, no high-protein diet, no prolonged fasting for more than one week, no planned change in the level of sports activity in the next 3 months),\n* With a personal history of anorexia nervosa, bulimia, or significant eating disorders according to the Investigator,\n* Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,\n* Having received, during the last 12 months, indemnities for clinical trial higher or equal to 6000 Euros,\n* Under legal protection (guardianship, wardship) or deprived of rights following an administrative or judicial decision,\n* Presenting a psychological or linguistic incapability to sign the ICF, Impossible to contact in case of emergency.",true,"ALL","50 Years","75 Years",{"count":22,"type":23},200,"ESTIMATED","INTERVENTIONAL",[26],"NA","The placebo-controlled, double blind parallel intervention trial \"PostWelLB\" aims to test whether 3 months of daily supplementation with the postbiotic product \"Humiome® Post LB\" (HPLB; 340 mg \u002F day) can reduce self-reported stress (PSS10 questionnaire)- in an older (50 - 75 years; all genders) population in France.",[29],"Stress",[31,32,33,34,35],"stress","wellbeing","healthy aging","postbiotic","microbiome","RECRUITING","2026-04-22",{"date":39,"type":40},"2026-04-23","ACTUAL",{"date":42,"type":23},"2026-04",{"date":44,"type":23},"2026-12",{"name":46,"class":47},"dsm-firmenich Switzerland AG","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"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","70 Years",{"count":59,"type":23},90,[26],"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.",[63,64],"Microbiome Dysbiosis","Gut Health",[66,35,67,68],"elderly","colon delivered b-vitamins","riboflavin","2026-03-17",{"date":71,"type":40},"2026-03-19",{"date":73,"type":40},"2025-07-18",{"date":75,"type":23},"2026-09",{"name":46,"class":47},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100601469","study-evaluating-the-effect-of-humiome-post-lb-on-stress-anxiety-and-cognition-in-aging-adults-100601469","NCT07110896","Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults","A Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults","AnexLB","Inclusion Criteria\n\n1. Participant is male or female, 50-75 years of age, inclusive.\n2. Participant has a Body Mass Index (BMI) of ≥18.5 kg\u002Fm2 to 32 kg\u002Fm2.\n3. Participant is generally in good health, as per investigator's judgement at V1.\n4. Participant has subjective mild to moderate memory complaints, as per investigator's judgement.\n5. Participant has a total score of ≥42 and ≤60 on the DASS-21 administered at V1.\n6. Participant is willing to maintain regular dietary, exercise, and allowed medication\u002Fsupplement habits and smoking and other nicotine habits (if a smoker or nicotine user) for the duration of the study.\n7. Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.\n\n7\\. Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.\n\nExclusion criteria:\n\n1. Participant has a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disease, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric\u002Fneurologic condition that, in the opinion of the investigator, could interfere with the interpretation of the study results.\n2. MMSE score at V1 \\\u003C 21.\n3. Chronic fatigue syndrome.\n4. Women: elevated stress and\u002For anxiety levels clearly related to the (peri) menopause complaints, as per investigator judgement\n5. Non-pharmacological or non-supplementation options for management of stress, anxiety or memory\u002Fcognitive complaints (e.g. yoga, \"brain jogging\") started within 4 weeks of screening 6. Participant has a clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder that, in the opinion of the investigator, could interfere with the interpretation of the study results.\n\n7\\. Participant has a condition that would likely cause immunosuppression. 8. Participant has a history of gastrointestinal surgery (cholecystectomy and appendectomy are acceptable, considering the prevalence in the age group), as per investigator judgement. 9. Participant has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥100 mm Hg) at screening.\n\n10\\. Participant has an issue with hearing or seeing that might interfere with the tasks\u002Fquestionnaires to be completed during the visits.\n\n11\\. Participant has used pre-, pro-, syn-, or post-biotic supplements within 90 days of screening.\n\n12\\. Participant has a history of using psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and\u002For narcotics within 4 weeks of screening. 13. Participants has major sleep disorder (severe insomnia) based on investigator's judgment.\n\n14\\. Participant has used sleep aid medications, supplements, and\u002For products, including antihistamines, within 2 weeks of screening (washout prior to screening is allowed). Sporadic use of supplementation of melatonin, valerian, passion flower, lavender, if needed, if this has been habitually or occasionally done prior to the study, is allowed. 15. Participant has used an acid-blocking medication (e.g., proton pump inhibitor, H2 blocker) in the past 30 days prior to study. However, any ongoing use started at least 12 weeks before Visit 1 is allowed.\n\n16\\. Participant has used selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines in the past 30 days. (Note: Participants will not be excluded on the basis of a well-managed depressive disorder that does not require SSRIs.) 17. Participant has a history of cancer in the prior 5 years. 18. Participant has an allergy to any components of the IP or the standardized breakfast.\n\n19\\. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 30 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).\n\n20\\. Participant has been exposed to any non-registered drug product within 30 days of the screening visit.\n\n21\\. Participant has a current or recent history (within 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as \\>14 drinks per week (1 drink = 350 ml beer, 150 ml wine, or 40 ml hard liquor).\n\n22\\. Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.\n\n23\\. Participant has a condition the investigator believes would interfere with his\u002Fher ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.",{"count":86,"type":23},236,[26],"To assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria) Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo",[90],"Healthy Aging",[92,93,29,94,95,96],"Healthy aging","Microbiome","Sleep","Anxiety","gut-brain","2026-03-09",{"date":99,"type":40},"2026-03-11",{"date":101,"type":40},"2025-08-01",{"date":103,"type":23},"2026-11",{"name":46,"class":47},3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":18,"minAge":114,"maxAge":57,"enrollmentInfo":115,"targetDuration":4,"studyType":24,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100584472","study-evaluating-the-efficacy-of-different-mixes-of-hmo-2fl--humiome-post-lb-on-ibs-gastrointestinal-symptoms-100584472","NCT06889779","Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms","A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of Two Different Mixes of HMO-2FL + Humiome® Post LB Postbiotic (Postbiotic-LB) on Gastrointestinal Symptoms in Irritable Bowel Syndrome (IBS) Subjects","DORPHI","* Written and signed informed consent (will be obtained before any study-related Assessments).\n* Male or female aged ≥18 - 70 years at the time of consent.\n* Female individuals of childbearing potential (Females who are peri or post-menopausal, i.e., when there has been no or irregular menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential.), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until:\n\n  * Sexual abstinence.\n  * Oral contraceptives.\n  * Trans-dermal patches or depot\n  * injection of a progestogen drug (starting at least 4 weeks prior to product administration).\n  * Double barrier method: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) plus spermicidal agent.\n  * Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration\u002F2 weeks prior screening).\n  * Contraceptives must be effective before the randomization visit.\n* Individuals with plasma FBG (fasting blood glucose) (less than equal to 125 mg\u002Fdl).\n* Individuals with Hemoglobin (Hb%) (more than equal to 10 g\u002Fdl).\n* Individuals with BP (blood pressure) (less than equal to 140\u002F100 mm Hg)\n* Individuals with normal haematology as assessed by CBC (complete blood counts)\n* Individuals with TSH levels in between 0.4 mIU\u002FL to 5.0 mIU\u002FL\n* Individuals with SGOT and SGPT within 2 X the Upper normal limit (ULN) and serum\n* Individuals with creatinine within 1.5 X ULN\n* Rome-IV diagnostic criteria: Individuals with more than 25% of bowel movements with Bristol stool types 1, 2 or 6,7 and have had recurrent abdominal pain, on average, at least 1 day\u002Fweek in the last 3 months. And the pain is associated with two or more of the following criteria:\n\n  * Related to defecation\n  * Associated with a change in frequency of stool\n  * Associated with a change in form or appearance of stool as\n  * assessed by Bristol stool types 1,2, 6 or 7.\n  * Individuals meeting the above criteria for the last 3 months with\n  * symptom onset at least 6 months before diagnosis\n* Individuals with Abdominal pain severity (more than equal to 6 on a 11-point scale) at screening and during placebo run-in period.\n* Individuals with IBS-SSS of at least 175 points at screening.\n* Individuals who are mentally stable as assessed by Perceived Stress Scale (PSS) less than equal to 26 (Low to Moderate stress).\n* Individuals who understand the nature and purpose of the study including the potential risks and side effects.\n* Individuals who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.\n* Individuals who are capable of filling the app-based digital form\u002Fdiary.\n\nExclusion Criteria:\n\n* Individuals with IBS-M.\n* Treatment with an investigational drug within 30 days\u002F5 half-lives of the drug (whichever longest) prior to screening visit.\n* Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer etc. (to be ruled out by physician based on prior history and physical examination).\n* Individuals with a history of surgical resection of the stomach, small intestine or large intestine.\n* Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis), colitis and enteritis.\n* Individuals with a history of any diet-based intolerance (gluten or lactose intolerance).\n* Individuals with a history of drug or alcohol abuse within the past 6 months.\n* Individuals with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).\n* Individuals with uncontrolled hypertension or on antihypertensive medications.\n* Individuals with serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.\n* Individuals who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.\n* Individuals with Type I or Type II diabetes mellitus.\n* Individuals with a history of or current diagnosis of any cancer diagnosed less than 5 years prior to screening. Individuals with cancer in full remission more than 5 years after diagnosis are acceptable.\n* Individuals who are immuno-compromised (HIV positive, on antirejection medication, rheumatoid arthritis and other autoimmune disorders).\n* Individuals with a history of abdominal surgery.\n* Individuals with diarrhoea of any other origin.\n* Individuals currently or in future planning to fast for more than 24 hours.\n* Individuals with an active eating disorder.\n* Individuals who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.\n* Individuals who have used pre\u002Fpro\u002Fpost\u002Fsynbiotic, Human Milk Oligosaccharides (HMOs), or fiber supplements (or probiotic\u002Ffiber enriched foods) or FODMAP diet or an antibiotic within 4 weeks prior to screening.\n* Individuals who have used IBS specific treatments within 4 weeks prior to screening.\n* Individuals who currently consume greater than 2 standard alcoholic drinks per day from past 3 months. ((One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer)\n* Smokers (in any number and any format)\n* Individuals with an allergy or sensitivity to the probiotic products.\n* Individuals who are cognitively impaired and\u002For who are unable to give an informed consent.\n* Individuals who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the Individuals' ability to complete the study or its measures or which may pose significant risk to the individual.","18 Years",{"count":116,"type":23},402,[26],"A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)",[120],"IBS (Irritable Bowel Syndrome)",[122],"Dietary supplement IBS",{"date":99,"type":40},{"date":125,"type":40},"2025-03-27",{"date":127,"type":23},"2026-07-30",{"name":46,"class":47},12,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":17,"sex":18,"minAge":114,"maxAge":20,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":139,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":154,"locationsCount":48},"100588163","the-effect-of-humiome-post-lb-on-gut-comfort-in-healthy-adult-volunteers-100588163","NCT06937814","The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers","The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers: a Double-blind, Randomized Placebo-controlled Study","Inclusion Criteria:\n\n1. Be able to give written informed consent.\n2. Self-reported gastrointestinal issues defined as 10-20 bowel movements per week and a score of 5-6 for ≥20% of stools based on the BSS in the 2 weeks prior to baseline, as assessed by the Qualified Investigator (QI).\n3. Self-reported GI issues such as bloating, mild cramping, and urgency, as assessed by the QI.\n4. Be between 18 and 75 years of age, inclusive.\n5. Have a BMI of between 18.5 - 29.9 kg\u002Fm2, inclusive.\n6. Self-reported stable body weight (\\\u003C5% change) over the past 3 months.\n7. Be in general good health, as determined by the QI.\n8. Willing to avoid consuming prebiotic, probiotic, postbiotics, fiber-rich and dietary supplements, anti-diarrheal and anti-constipation medication until the end of the study (see Section 5.6).\n9. Willing to maintain current dietary habits and lifestyle, including level of physical activity, allowed medication\u002Fsupplements habits for the duration of the study.\n10. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,\n\nIndividuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:\n\n* Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)\n* Double-barrier method\n* Intrauterine devices\n* Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)\n* Vasectomy of partner at least 6 months prior to screening\n* Abstinence and agrees to use contraception if planning on becoming sexually active during the study\n\nExclusion Criteria:\n\n1. Failure to meet any one of the inclusion criteria.\n2. Females who are pregnant, lactating or wish to become pregnant during the study.\n3. Are lactose intolerant or have any other hypersensitivity\u002Fallergy to any of the components of the test product.\n4. Meeting Irritable Bowel Syndrome (IBS) diagnostic criteria as defined by Rome IV criteria, i.e. having recurrent abdominal pain on average at least 1 day\u002Fweek in the last 3 months, associated with two or more of the following criteria:\n\n   1. Related to defecation.\n   2. Associated with a change in frequency of stool.\n   3. Associated with a change in form (appearance) of stool. Criteria need to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.\n5. Have suffered from diarrhea (defined as ≥3 bowel movements per day and 6-7 on BSS) at any time two weeks prior to run-in, as assessed by the QI.\n6. Experience alarm features such as weight loss, rectal bleeding, or recent change in bowel habit (\\\u003C3 months), as assessed by the QI.\n7. Have taken antibiotics within the previous 2 months prior to the run-in period as assessed by QI (see Section 5.6.1).\n8. Unstable hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg). Treatment on a stable dose of medication for at least 3 months will be considered by the QI.\n9. Known history of or ongoing HIV, hepatitis or clinically important, as judged by the QI, endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary conditions.\n10. Current or history of any significant diseases of the gastrointestinal tract (including but not limited to Crohn's disease, ulcerative colitis, celiacs disease, colectomy), as assessed by the QI.\n11. Have planned a major surgery during the study period as assessed by the QI.\n12. Have a history of drug and\u002For alcohol abuse in the past 12 months at the time of enrolment.\n13. Alcohol intake average of \\>2 standard drinks per day as assessed by the QI\n14. Have made any major dietary changes in the past 3 months prior to run-in period.\n15. Currently consuming a vegetarian or vegan diet.\n16. Are planning a holiday over the study period that would alter dietary patterns as assessed by the QI.\n17. Have planned major changes in lifestyle (i.e. diet, weight loss program, exercise level, travelling) during the duration of the study.\n18. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period.\n19. Chronic use of cannabinoid products (\\>2 times\u002Fweek). Occasional users will be required to abstain for the duration of the study period.\n20. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant.\n21. Participation in other clinical research studies 30 days prior to the run-in period, as assessed by the QI.",{"count":138,"type":23},250,[26],"The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on bowel movements in healthy adult volunteers compared to Placebo adjusted on baseline. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nDoes Humiome ® Post LB improve bowel movements with self-reported GI issues?\n\nParticipants will be provided Humiome ® Post LB (170 mg) for 8 weeks and asked to complete a study diary, questionnaires, and stool samples.",[142,143,144],"GI Issues","Bowel Movements","Gastrointestinal Symptoms",[146,147,148],"Bowel movements","Gastrointestinal symptoms","Bristol stool scale","2026-03-05",{"date":97,"type":40},{"date":152,"type":40},"2025-06-16",{"date":42,"type":23},{"name":46,"class":47},""]