[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nimble Science Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,70,105,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100633365","phase-4-assessing-changes-in-the-gut-microbiome-of-non-gastrointestinal-disordered-subjects-before-and-after-oral-prebiotic-supplementation-using-the-simba-capsule-100633365",false,"NCT07525739","Assessing Changes in the Gut Microbiome of Non-Gastrointestinal Disordered Subjects Before and After Oral Prebiotic Supplementation Using the SIMBA Capsule","Inclusion Criteria:\n\n1. Aged 19-40 years old at the inclusion of the study, both female and male subjects.\n2. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.\n3. Willing to maintain their current lifestyle during the study.\n4. Able to swallow a 25mm length and 9mm width sized capsule.\n5. At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study.\n6. Signed Informed Consent, and willing to follow the study procedures, including consumption of study product per the protocol and completing any forms\u002Fquestionnaires needed throughout the study.\n\nExclusion Criteria:\n\n1. Use of any prescription medication within 14 days prior to the start of the study, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant (excluding oral contraceptives).\n2. Any current acute or chronic medical condition, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant.\n3. Known or suspected history of any gastrointestinal disease including, but not limited to, irritable bowel syndrome, celiac disease (treated or untreated), inflammatory bowel disease, persistent diarrhea, chronic constipation, gastrointestinal malignancy, or any condition known to affect gastrointestinal motility or absorption.\n4. Less than 3 bowel movements a week\n5. If using Proton Pump Inhibitors (PPIs), unable to stop for PPIs 24hrs prior to SIMBA capsule ingestion and 4 hours after\n6. Prior gastrointestinal surgery, or radiation treatment which, in the Investigator's opinion, may lead to intestinal stricturing or obstruction with a risk of capsule non-excretion, including, e.g., untreated achalasia, eosinophilic esophagitis, cancer diagnosis (depending on timing, location, and treatment) or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.\n7. History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction.\n8. Organic motility disorder (e.g., gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome) with a history of swallowing difficulty or oropharyngeal dysphagia.\n9. Use of metformin within 3 months prior to the start of the study\n10. Use of any oral or intravenous antibiotics within 3 months prior to the baseline study timepoint (topical antibiotics are acceptable).\n11. Use of probiotics, prebiotics, fibre (Metamucil, FibreOne, etc.) or any other supplements known to affect the gastrointestinal microbiota within 14 days prior to the baseline study timepoint.\n12. Known or suspected allergy or intolerance to the IP or its components.\n13. Pregnant or breastfeeding women.\n14. Excessive alcohol consumption or drug abuse.",true,"MALE","19 Years","40 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.",[27,28,29,30],"Prebiotic","Metagenomic Next Generation Sequencing","Microbiome","Small Intestine","NOT_YET_RECRUITING","2026-04-06",{"date":34,"type":35},"2026-04-13","ACTUAL",{"date":37,"type":21},"2026-05",{"date":39,"type":21},"2026-09",{"name":41,"class":42},"Nimble Science Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100570190","phase-1-assessing-gut-microbiome-changes-before-and-after-an-oral-nutritional-supplement-intake-using-the-simba-capsule-in-diabetic-participants-100570190","NCT06704022","Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants","Inclusion Criteria:\n\n1. Aged 40-65 years old at the inclusion of the study, both female and male subjects.\n2. Has type 2 diabetes as evidenced by their medical history charts and is able to maintain number of medications, type and dose throughout the duration of the study.\n3. Has HbA1c ≥ 6.5% and ≤ 9.5% based on a blood sample collected at the Screening Visit, documented within the past month or referred by a medical doctor.\n4. Normal to overweight (BMI 20-29.9).\n5. Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit.\n6. Is taking a maximum of 3 oral anti-diabetic drugs, one of which must be Metformin. Other class of medications permitted include: Sulfonylurea, SGLT2 inhibitors, and DPP4 inhibitors.\n7. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.\n8. Willingness to follow the protocol as described, including consumption of study product per the protocol and completing any forms\u002Fquestionnaires needed throughout the study.\n9. The participant is willing to refrain from taking non-study diabetes-specific oral nutritional formulas over the entire course of the study.\n10. Willing to maintain their diet and physical activity levels during the study.\n11. Able to swallow a 25mm length and 9mm width sized capsule.\n12. At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study. Signed Informed Consent; willing and able to comply with study procedures\n\nExclusion Criteria:\n\n1. Confirmed type 1 diabetes and\u002For had a history of diabetic ketoacidosis.\n2. Use of exogenous insulin or GLP1 agonists for glucose control.\n3. Using diabetes-specific oral nutritional supplements(s), (e.g. Glucerna®, Boost etc.) defined as more than one eating occasion per week within the past 4 weeks (those users who can stop using such products for ≥4 weeks before baseline visit need not be excluded).\n4. Follows a non-typical eating pattern such as very low carbohydrate diet (e.g., Adkins diet, ketogenic diet, high protein diet).\n5. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the investigators.\n6. Galactosemia and lactose intolerance\n7. A chronic disease which in the opinion of the investigator, would adversely affect study safety or outcome. Such as, but not limited to\n\n   * A significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure, per physician evaluation.\n   * End-stage organ failure (such as end-stage renal disease) or is post-organ transplant.\n   * Current or history of renal disease or on dialysis or severe gastroparesis.\n   * Current diagnosed hepatic disease such as liver cirrhosis or late-stage liver fibrosis. Participants with prevalent angina will not be excluded.\n8. A chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis C, or HIV.\n9. Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment.\n10. Taking any herbals, dietary supplements, or medications during the past four weeks prior to baseline visit that could profoundly affect (in the opinion of the principal investigator or site physician) blood glucose, body weight, muscle, metabolism, appetite or microbiome (e.g. orlistat, contrave) (naltrexone\u002Fbupropion), Qsymia (phentermine\u002Ftopiramate), Belviq (lorcaserin), incretin mimetics, other drugs indicated for weight loss, cannabis, glucocorticoids, prebiotics and probiotic supplements). Those users who have stopped using such supplements\u002F medications for ≥4 weeks prior to baseline need not be excluded).\n11. Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the SIMBA capsule ingestion timepoints. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.\n\n    \\- If willing prokinetic use can be discontinued for the study duration, with a washout period of 2 weeks\n12. Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.\n13. Current infection (requiring medication and antibiotics), inpatient surgery or received systemic corticosteroid treatment \\[except for inhaled (includes nasal), topical, and ophthalmic steroids\\] in the last 3 months.\n14. Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would interfere with consumption or digestion or absorption of study product, lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.\n\n    \\- Diagnosed with Crohn's disease, ulcerative colitis or celiac disease.\n15. History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.\n16. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.\n17. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.\n18. History of less than three (3) bowel movements per week. 13) Consumption of probiotic or prebiotic capsule supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.\n19. Any prior Fecal Microbiota Transplantation.\n20. Colon cleanses\u002Fbowel prep for 2 weeks.\n21. Clotting or bleeding disorders (the use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws will be allowed as per physician's opinion).\n22. Has blood or blood-related diseases (e.g. hemophilia, thalassemia, sickle cell disease, hereditary spherocytosis, glucose-6-phosphate dehydrogenase deficiency).\n23. Received a blood transfusion within the last 3 weeks.\n24. Allergic or intolerant to any ingredient found in the study products.\n25. Habitually engages in strenuous exercise (e.g., high intensity aerobic exercise, including heavy physical labor), duration of 1 hour or longer, 3 or more times per week. Potential participants may be eligible to participate if their levels exercise are reduced.\n26. Participant is actively enrolled in a weight loss program.\n27. Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed.\n28. Pregnant or breastfeeding.\n29. Planning to become pregnant.","ALL","65 Years",{"count":20,"type":21},[54],"PHASE1","This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) .",[57],"Type 2 Diabetes",[59,60,61],"oral nutritional supplement","microbiome","small intestine","2025-08-07",{"date":64,"type":35},"2025-08-11",{"date":66,"type":21},"2025-09",{"date":68,"type":21},"2026-08",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":50,"minAge":76,"maxAge":51,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},"100540484","the-safety-and-efficacy-of-a-probiotic-intervention-on-lactulose-hydrogen-breath-test-positive-patients-and-related-gastrointestinal-symptoms-100540484","NCT06317441","The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms","Inclusion Criteria:\n\n1. Aged 18-65 years old at the inclusion of the study, both female and male subjects.\n2. Signed Informed Consent; willing and able to comply with study procedures.\n3. Willing to maintain their diet and physical activity levels during the study.\n4. Able to swallow a size-00 capsule (23mm length and 9mm width).\n5. Participants with at least one of the following Rome IV diagnoses: FABD, functional diarrhea, IBS-M, or IBS-D.\n6. Baseline weekly average of worst daily (in past 24 hours) abdominal bloating\u002Fdistension score of \\>= 3.0 on a 0-to-10-point scale.\n7. Participants with abnormal LHBT following the North American Consensus recommendations (A rise in hydrogen of ≥20 ppm by 90 min).\n\nExclusion Criteria:\n\n1. History of less than three (3) bowel movements per week.\n2. With the diagnosis of IBS-C.\n3. Prior gastrointestinal disease, surgery, or abdominal or pelvic radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, any IBD, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.\n4. Persons with central venous catheters.\n5. History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.\n6. Known history abdominal radiation treatment.\n7. Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, or GLP-1 analogues); laxative use is allowed if used less than 3 times a week and it is willing to keep unchanged in the week prior to the SIMBA capsule ingestions. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.\n\n   o Prokinetic use. Potential participants who are not using prokinetics to treat SIBO may be eligible after a 2-week washout period, and willing to not use prokinetics for the study duration.\n8. Unable to stop using laxatives or prokinetic medications for 4 days before the study procedure (BT). Laxatives can be resumed after the test is conducted.\n9. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.\n10. Celiac disease (treated or untreated).\n11. Any significant heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.\n12. Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).\n13. Gastrointestinal inflammatory diseases, including ulcerative colitis, Crohn's disease, microscopic colitis.\n14. Participants with IBS presenting with alarm symptoms such as: rectal bleeding, unexplained weight loss, iron deficiency anemia, and nocturnal symptoms,\n15. Participants over the age of 50 or older who have not had:\n\n    * a colon cancer screening by either a negative FIT or FOBT test within the last 2 years; OR\n    * a colonoscopy in the prior 10 years which was negative for colorectal cancer\n16. Epilepsy diagnosis.\n17. History or diagnosis of immunological diseases, infectious diseases or immune-compromised conditions, which in the opinion of the investigator, would adversely affect study safety or outcome. Such as, but not limited to, hepatitis, tuberculosis, HIV positive, Parkinson's, multiple sclerosis, AIDS, lymphoma, and long-term corticosteroid treatment.\n18. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.\n19. Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.\n20. Regular use of probiotics, prebiotics or synbiotics (including food and drinks containing added probiotics and\u002For probiotic yogurts with live, active cultures) within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.\n21. Any prior Fecal Microbiota Transplantation.\n22. Pregnant or breastfeeding.\n23. Planning to become pregnant.\n24. Alcohol or drug abuse.\n25. Allergy to the components present in the probiotic and placebo capsules.\n26. Are non-English speaking.\n27. Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed.","18 Years",{"count":78,"type":21},105,[80],"NA","The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms, gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth (SIBO). Two doses of probiotic will be evaluated against placebo.",[83,84],"Small Intestinal Bacterial Overgrowth","SIBO",[86,87,88,89,90,91,92,93,94,95],"Functional abdominal bloating and distension","Functional Diarrhea","Irritable Bowel Syndrome with Diarrhea","Irritable Bowel Syndrome","Abdominal Bloating","IBS","IBS-D","FABD","Functional Gastrointestinal Disorders","FGID","RECRUITING","2025-04-24",{"date":99,"type":35},"2025-04-29",{"date":101,"type":35},"2024-07-20",{"date":103,"type":21},"2026-12",{"name":41,"class":42},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":15,"sex":50,"minAge":76,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":123,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":43},"100487945","evaluation-of-the-simba-capsule-for-small-intestinal-dysbiosis-100487945","NCT05633706","Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis","Evaluation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule for Small Intestinal Dysbiosis","Inclusion Criteria:\n\n1. 1\\. Aged between 18 and 80 years.\n2. No previous diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, Functional Dyspepsia, and T2D by participant self-report (Control group).\n3. Prior diagnosis of Celiac Disease, Ulcerative Colitis, Crohn's disease, IBS, or Functional Dyspepsia, and T2D by a relevant physician, nutritionist, naturopath, etc, and willingness to provide documentation to confirm this diagnosis or have a consultation with the PI. (Disease group).\n4. Ability to understand and provide informed consent.\n5. Ability and willingness to meet the required schedule, study interventions, and questionnaire requirements.\n6. No planned change in diet or medical interventions during the study duration.\n\nExclusion Criteria\n\n1. Known disease which, in the investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months prior to enrollment are acceptable). The main deciding factor would be a history of obstructive symptoms in the previous 3 months prior to entry.\n2. Use of any medications or having undergone procedures in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, laxatives, or GLP-1 analogues).\n\n   1. Stimulant laxative use (includes bisacodyl\u002FDulcolax, senna\u002FSenekot, cascara, or fibre supplments) is allowed if it is kept unchanged in the week prior to the SIMBA Capsule ingestion. Osmotic laxatives (polyethylene glycol (PEG; other trade names), milk of magnesia, lactulose), stool softeners (docusate; other trade names) or secretagogues (linaclotide\u002FConstella, plecanatide\u002FTrulance, tenapanor\u002FIbsrela should not be used within 7 days of taking the SIMBA capsules.\n   2. Prokinetics use is allowed if kept unchanged in the week prior to the SIMBA Capsule ingestion (includes domperidone, metoclopramide, prucalopride). Inconsistent use of prokinetics will be evaluated by the PI.\n   3. PPI or H2RA use. Must be able to discontinue PPI or H2RA medications 48hrs prior to SIMBA capsule ingestion, medication can be resumed 4 hours after ingestion.\n3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.\n4. History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction\n5. History of abdominal radiation treatment\n6. Females of childbearing age who are pregnant or lactating by self-report. (should an X-ray be required for confirmation of capsule passage, a urine pregnancy test will be administered beforehand).\n7. No antibiotics, or colon cleanses\u002Fbowel prep for 2 weeks.\n8. \\\u003C 2 bowel movements per week (Control Group only).","80 Years",{"count":114,"type":21},300,"OBSERVATIONAL","The SIMBA Capsule is a small, single-use, ingestible capsule that allows for the non-invasive sampling of small bowel contents using purely mechanical means. The study will compare the microbial and metabolomics analysis from the sample collected with the capsule series, to same-participant symptom questionnaires and stool microbial analysis.",[89,118,119,120,121,57,122],"Crohn Disease","Celiac Disease","Ulcerative Colitis","Functional Dyspepsia","Healthy",[29],"2025-04-10",{"date":126,"type":35},"2025-04-15",{"date":128,"type":35},"2023-01-09",{"date":130,"type":21},"2025-06-06",{"name":41,"class":42},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":15,"sex":50,"minAge":76,"maxAge":51,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":43},"100570056","phase-1-assessing-the-safety-of-an-igy-supplement-on-the-gut-microbiome-100570056","NCT06702280","Assessing the Safety of an IGY Supplement on the Gut Microbiome","Inclusion Criteria:\n\n1. Aged 18-65 years old at the inclusion of the study, both female and male subjects.\n2. Signed Informed Consent; willing and able to comply with study procedures.\n3. Willing to maintain their diet and physical activity levels during the study.\n4. Able to swallow a 25mm x 9mm sized capsule\n\nExclusion Criteria:\n\n1. Use of regular prescription medications, including antihypertensives, anti-inflammatory drugs, corticosteroids, immunosuppressants, antidepressants, antipsychotics, anti-diabetic medications, and anti-arrhythmic agents, which in the opinion of the investigator, would adversely affect study safety or outcome.\n2. Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.\n3. History of known structural gastrointestinal abnormalities such as structures or fistulas which may lead to mechanical obstruction.\n4. Use of any medications in the week prior to the SIMBA or LIMBA capsule ingestions, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, GLP-1 analogues); laxative and prokinetic use is allowed if it is kept unchanged in the week prior to the SIMBA and LIMBA capsule ingestions. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the capsules and PPI treatment is resumed only 4 hours thereafter.\n5. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.\n6. Any significant gastrointestinal, heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.\n7. Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).\n8. History or diagnosis of immunological or infectious disease (hepatitis, tuberculosis, HIV, Parkinson's).\n9. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.\n10. Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.\n11. Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.\n12. Any prior Fecal Microbiota Transplantation.\n13. Colon cleanses\u002Fbowel prep for 2 weeks\n14. Pregnant or breastfeeding.\n15. Planning to become pregnant.\n16. Alcohol or drug abuse.\n17. Egg allergy\n18. Vegan diet, or other diet where ingestion of eggs is not suitable\n19. History of less than 3 bowel movements per week.\n20. Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed",{"count":139,"type":21},20,[54],"This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.",[122,29],"2024-11-20",{"date":145,"type":35},"2024-11-22",{"date":147,"type":21},"2025-02",{"date":149,"type":21},"2025-10",{"name":41,"class":42},""]