[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou Zhiyi Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100535070","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-live-sk08-powder-in-patients-with-ibs-d-100535070",false,"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.","ALL","18 Years","70 Years",{"count":20,"type":21},1298,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Irritable Bowel Syndrome With Diarrhea","RECRUITING","2025-03-31",{"date":31,"type":32},"2025-04-03","ACTUAL",{"date":34,"type":32},"2024-03-16",{"date":36,"type":21},"2027-01",{"name":38,"class":39},"Guangzhou Zhiyi Biotechnology Co., Ltd.","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100571804","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-live-sk08-powder-in-adult-patients-with-active-mild-to-moderate-ulcerative-colitis-100571804","NCT06725017","A Phase 2 Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Adult Patients with Active Mild to Moderate Ulcerative Colitis","A Phase 2, Multi-center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroides Fragilis) in Adult Patients with Active Mild to Moderate Ulcerative Colitis","Inclusion Criteria:\n\n1. Subjects who voluntarily sign the informed consent form and are able to comply with the study protocol and have the ability to follow relevant procedures.\n2. Male and female subjects aged 18-75 years (inclusive) at the time of signing the informed consent.\n3. Ulcerative colitis diagnosed by routine clinical, endoscopy, and pathologic criteria for at least 3 months.\n4. Subjects with active mild to moderate UC as defined by modified Mayo Score (mMS) of 4-10 (both inclusive), including an endoscopy sub-score of at least 2 and a rectal bleeding sub-score of at least 1.\n5. The lesion extends beyond the rectum (colonoscopy shows that the lesion is \\> 15 cm from the anal verge).\n6. Have had no response to, an inadequate response to, or an intolerance to standard 5-ASA treatment (including 5-ASA local treatment), no response or inadequate response means patients have persistent symptoms during treatment with 5-ASA at the recommended dose and treatment duration, intolerance means patients discontinue the 5-ASA treatment due to adverse events. Subjects receiving concurrent stable dose 5-ASA (i.e. no change in medication within 4 weeks of study enrollment and is not expected to change during the study) are permitted to be enrolled.\n7. If female, the subject is non-lactating, and is either: Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; Of childbearing potential and is practicing at least 1 highly effective method of birth control including the barrier method; oral or parenteral contraceptives; a vasectomized partner; or abstinence from sexual intercourse from the time of signing informed consent and until at least 3 months after the last dose of the study drug. The Investigator will discuss with the subject the option of practicing more than 1 of the above methods for the duration of the study. Subjects must have a negative serum pregnancy test within 7 days prior to the first dose of the study drug.\n8. If male and partner is of childbearing potential, the subject agrees to practice at least one highly effective method of birth control from the time of signing the informed consent until at least 3 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Subjects with Crohn's disease, radiation colitis, diverticulitis, ischemic colitis, microscopic colitis, drug-related (e.g., NSAIDs, tretinoin, immune checkpoint inhibitors, mycophenolate, etc.) colitis, patients with indeterminate colitis, and patients with endoscopy\u002Fbiopsy showing ileitis\u002Fgranulomas with clinical suspicion of Crohn's disease.\n2. Malignancy or history of malignancy within the previous 5 years except for resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence.\n3. Subjects who received surgery within 30 days before the first dose of study drug or who plan to undergo surgery during the study.\n4. Subjects with other pathological conditions in the intestine, including colon dysplasia, intestinal stricture, tumor, intestinal fistula, intestinal obstruction, celiac disease, etc.\n5. Presence of any active or chronic recurrent infections.\n6. Subjects with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy).\n7. Subjects with severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, immune, cardiovascular, respiratory, neurological, or psychiatric disease.\n8. Subjects with poor concurrent medical risks with a clinically significant co-morbid disease such that, in the opinion of the Investigator, the subject should not be enrolled including: Subjects with decompensated liver cirrhosis (Child-Pugh Class B or C) or uncontrolled liver disease; History of pancreatitis; QTc \\> 450 msec or QTc \\> 480 msec for participants with bundle branch block at screening and Day 1. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF); Prior history of bone marrow transplant; Known Hypogammaglobulinemia; Known severe immunodeficiency; AST ≥ 2 × the upper limit of normal (ULN) and\u002For ALT ≥ 2 × ULN and\u002For total bilirubin ≥ 2 × ULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m² by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation; Absolute neutrophil count (ANC) \\\u003C 500 cells\u002FμL.\n9. Subjects with anti-hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, or hepatitis B surface antigen (HBsAg) positive and need antiviral therapy during the screening period.\n10. Subjects have known or suspected hypersensitivity to the study drug and its excipients (maltodextrin, silicon dioxide, magnesium stearate).\n11. Subjects who cannot discontinue steroid hormones (such as budesonide multi-matrix (MMX)) oral\u002Ftopical (suppositories, enemas, etc.), or systemic corticosteroids within 2 weeks before the first dose of study drug.\n12. Patients who cannot discontinue other drugs that affect gastrointestinal function, including systemic antibiotics, anti-diarrheal agents, etc., within 2 weeks before the first dose of study drug.\n13. Received any probiotic medicines or fecal bacteria transplant within 30 days prior to the first dose.\n14. Received treatment with biological agents (infliximab, adalimumab, golimumab, certolizumab, vedolizumab, ustekinumab, natalizumab, etc.) within 8 weeks before the first dose (or 5 half lives of the drug); or received any non-biological agents (cyclosporine, tacrolimus, thalidomide, methotrexate, tofacitinib, etc.) treatment within 30 days before the first dose (or 5 half-lives of the drug).\n15. Received (attenuated) live vaccination within 4 weeks of Day 1 or plan to receive during the study until follow-up.\n16. Subjects who have participated in any clinical trial within 3 months before screening.\n17. Subjects with a history of alcohol and drug abuse.","75 Years",{"count":49,"type":21},60,[51],"PHASE2","This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to preliminarily evaluate the efficacy and safety of SK08 in adult patients with active mild to moderate UC. Each subject will undergo three study periods: screening, induction treatment period and a safety follow-up period.",[54],"Ulcerative Colitis (UC)",[56],"Ulcerative Colitis","NOT_YET_RECRUITING","2024-12-11",{"date":60,"type":32},"2024-12-16",{"date":62,"type":21},"2025-07-01",{"date":64,"type":21},"2027-08-01",{"name":38,"class":39},""]