[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"irritable-bowel-syndrome-with-diarrhea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:irritable-bowel-syndrome-with-diarrhea":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,73,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641679","effects-of-the-multispecies-probiotic-ecologic-barrier-in-ibs-patients-with-upper-gi-symptoms-and-anxiety-depression-or-stress-100641679",false,"NCT07656623","Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress","The Effects of the Multispecies Probiotic Mixture Ecologic Barrier for Patients With Irritable Bowel Syndrome With Upper Gastrointestinal Symptoms and Having Anxiety, Depression, and Stress Symptoms","Inclusion Criteria:\n\n* Indication for upper endoscopy and colonoscopy;\n* Diagnosed with IBS-D according to Rome IV criteria;\n* Presence of at least one upper gastrointestinal symptom, including: retrosternal burning, reflux, epigastric pain, epigastric burning, postprandial discomfort, early satiety, abdominal bloating, belching, sour regurgitation, nausea\u002Fvomiting;\n* Manifestations of anxiety, depression, or stress, with at least one of the three DASS-21 subscale scores exceeding the normal threshold (depression score \\>9 and\u002For anxiety score \\>7 and\u002For stress score \\>14).\n\nExclusion Criteria:\n\n* Positive for Helicobacter pylori by rapid urease test during endoscopy or by 13C-urea breath test;\n* Currently using anxiolytic or antidepressant medication;\n* Currently or previously used antibiotics within the past month;\n* Currently or previously used symptomatic treatment, probiotics, or proton pump inhibitors (PPI) within the past two weeks;\n* History of gastrointestinal surgery;\n* Endoscopic findings of organic lesions: ulcer, acute inflammation, colonic polyp \\>5 mm, or colonic polyp \\\u003C5 mm with suspected neoplasia;\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","The aim of this clinical trial is to find out whether Ecologic Barrier is effective in supporting the treatment of irritable bowel syndrome (IBS) in adults. The main questions that this trial aims to answer are:\n\n* Does Ecologic Barrier help improve IBS severity when added to standard IBS treatment?\n* Does Ecologic Barrier help improve symptoms of anxiety, depression, and stress in patients with IBS?\n* Does Ecologic Barrier help improve upper gastrointestinal symptoms when added to standard IBS treatment?\n* What adverse events may occur when using Ecologic Barrier? The researchers will compare a group receiving standard symptom-based treatment with another group receiving standard treatment plus Ecologic Barrier.\n\nParticipants will:\n\n* Receive IBS treatment for 2 months, with Ecologic Barrier added during either the first month or the second month, depending on random assignment.\n* Attend a follow-up visit after 1 month of treatment.\n* Take part in interviews about IBS severity, symptom improvement, adverse events, and symptoms of depression and anxiety at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.",[26],"Irritable Bowel Syndrome With Diarrhea",[28,29,30,31,32,33,34,35],"Irritable bowel syndrome","IBS-D","Probiotics","DASS-21","Upper gastrointestinal symptoms","Stress","Depression","Anxiety","RECRUITING","2026-06-15",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2024-06-01",{"date":44,"type":20},"2026-06-30",{"name":46,"class":47},"Institute of Gastroenterology and Hepatology, Vietnam","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100535070","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-live-sk08-powder-in-patients-with-ibs-d-100535070","NCT06247046","A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D","A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroidetes Fragilis) in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)","Inclusion Criteria:\n\n* 1.Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.\n* 2\\. Age between 18 and 70 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.\n* 3\\. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (1) Abdominal pain is related to defecation; ② Abdominal pain accompanied by changes in the frequency of defecation; ③ Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was \\>25% for Bristol fecal trait type 6 or 7, and \\\u003C25% for Bristol fecal trait type 1 or 2 (see Appendix 13.3: IBS Rome IV diagnostic criteria and subtype classification criteria).\n* 4\\. Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was \\>5mm or the number of intestinal polyps was \\>3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.\n* 5\\. Colonoscopy or endoscopy should be performed at least 4 weeks before the run-in period, and IBS symptoms still occur before the run-in period.\n* 6\\. During the run-in period, the average number of days with type 6 or type 7 fecal traits per week was ≥4 days, and the average NRS score (the highest score within 24 hours) of daily abdominal pain intensity on days with type 6 or type 7 fecal traits was ≥3.0.\n* 7\\. Patients completed diary at least 5 days in the week before randomization (D-7 to D-1) and at least 10 days in the 2 weeks before randomization (D-14 to D-1).\n* 8\\. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.\n* 9\\. During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns.\n\nExclusion Criteria:\n\n* 1\\. Patients with constipated, mixed and amorphous IBS.\n* 2\\. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).\n* 3\\. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.\n* 4\\. Known to have lactose intolerance and celiac disease.\n* 5\\. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as nonphysiologic ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.\n* 6\\. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section or tubal ligation without intestinal complications, hernia repair.\n* 7\\. Patients with a previously diagnosed psychiatric disorder or moderate to severe depression or generalized anxiety disorder requiring medication (PHQ-9≥10 or GAD-7≥10 during screening).\n* 8\\. Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant.\n* 9\\. People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage.\n* 10\\. Laboratory tests showed significant abnormalities, and the investigator determined that the patient's participation in the study may compromise his or her safety, including but not limited to: (i) Creatinine ≥1.5 times the upper limit of normal (ULN); (ii) AST≥2 times upper limit of normal (ULN) and\u002For ALT≥2 times upper limit of normal (ULN) and\u002For total bilirubin ≥1.5 times upper limit of normal (ULN).\n* 12\\. A history of drug or alcohol abuse.\n* 13\\. Even with the help of liquids, patients are unable to take oral solid dosage forms.\n* 14\\. Allergic to experimental drugs, rescue drugs and their ingredients.\n* 15\\. During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succinylcholine), antidiarrheal agents (such as loperamide, montmorillonite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc\n* 16\\. A woman who is pregnant or breastfeeding.\n* 17\\. At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan.\n* 18\\. Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent.\n* 19\\. The patient had previously participated in a clinical study of SK08.\n* 20.According to the judgment of the investigator, the participants are not suitable to participate in this clinical trial.","70 Years",{"count":58,"type":20},1298,[60],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Live SK08 Powder compared with placebo in the treatment of participants with irritable bowel syndrome with diarrhea.",[26],"2025-03-31",{"date":65,"type":40},"2025-04-03",{"date":67,"type":40},"2024-03-16",{"date":69,"type":20},"2027-01",{"name":71,"class":47},"Guangzhou Zhiyi Biotechnology Co., Ltd.",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":72},"100563149","early-phase-1-bsubtilis-attenuate-symptoms-in-diarrhea-predominant-irritable-bowel-syndrome-by-increasing-hypoxanthine-biosynthesis-100563149","NCT06612411","B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis","Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome","Inclusion Criteria:\n\nPatients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included.\n\nExclusion Criteria:\n\nSubjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study.\n\nSubjects who decline to participate into the study.",true,"16 Years","80 Years",{"count":84,"type":20},180,[86],"EARLY_PHASE1","This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.",[89,90],"Irritable Bowel Syndrome with Diarrhea","Purine Metabolism Disorder","2024-09-24",{"date":93,"type":40},"2024-09-25",{"date":42,"type":40},{"date":96,"type":20},"2024-12-31",{"name":98,"class":47},"Jinling Hospital, China",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100538944","phase-2-efficacy-and-safety-of-fmt-for-the-treatment-of-ibs-d-and-mental-health-comorbidity-in-young-adults-100538944","NCT06297421","Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults","Efficacy and Safety of Fecal Microbiota Transplantation for the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults: A Randomized, Double-blind, Placebo Controlled Study","Inclusion Criteria:\n\n1. Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.\n2. Age between 18 and 29 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.\n3. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (a) Abdominal pain is related to defecation; （b） Abdominal pain accompanied by changes in the frequency of defecation; （c） Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was \\>25% for Bristol fecal trait type 6 or 7, and \\\u003C25% for Bristol fecal trait type 1 or 2；and a Hamilton Depression Scale score: 20-34 and\u002For a Hamilton Anxiety Scale score: 14-28 were evaluated as depressed or anxious patients;\n4. Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was \\>5mm or the number of intestinal polyps was \\>3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.\n5. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.\n6. During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns.\n\nExclusion Criteria:\n\n1. Patients with constipated, mixed and amorphous IBS.\n2. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).\n3. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.\n4. Known to have lactose intolerance and celiac disease.\n5. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.\n6. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section but no intestinal complications, hernia repair.\n7. Patients with severe mental disorders other than depression and anxiety.\n8. Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant.\n9. People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage.\n10. Laboratory tests showed significant abnormalities, and the investigator determined that the patient's participation in the study may compromise his or her safety, including but not limited to: (i) Creatinine ≥1.5 times the upper limit of normal (ULN); (ii) AST≥2 times upper limit of normal (ULN) and\u002For ALT≥2 times upper limit of normal (ULN) and\u002For total bilirubin ≥1.5 times upper limit of normal (ULN).\n11. A history of drug or alcohol abuse.\n12. Even with the help of liquids, patients are unable to take oral solid dosage forms.\n13. Allergic to experimental drugs, rescue drugs and their ingredients.\n14. During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succinylcholine), antidiarrheal agents (such as loperamide, montmorillonite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc.\n15. A woman who is pregnant or breastfeeding.\n16. At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan.\n17. Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent.\n18. The patient had previously participated in a clinical study of FMT and received FMT therapy.\n19. According to the judgment of the investigator, the participants are not suitable to participate in this clinical trial.","29 Years",{"count":108,"type":20},88,[110],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults.",[26,113,114],"Fecal Microbiota Transplantation","Mental Health Issue",[89,113,116,117,118],"Randomized Controlled Study","Mental Health Comorbidity","Young Adults","NOT_YET_RECRUITING","2024-07-12",{"date":122,"type":40},"2024-07-16",{"date":124,"type":20},"2024-09",{"date":126,"type":20},"2026-06",{"name":128,"class":47},"Shenzhen Hospital of Southern Medical University"]