Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroidetes Fragilis) in Treating Patients With Irritable Bowel Syndrome With Diarrhea
Led by Guangzhou Zhiyi Biotechnology Co., Ltd. · Updated on 2025-04-03
1298
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Live SK08 Powder compared to a placebo in treating adults with irritable bowel syndrome with diarrhea (IBS-D). IBS-D is a chronic condition causing abdominal pain, bloating, and changes in bowel habits, with no detectable organic lesions. The study aims to assess how SK08 may relieve symptoms by protecting the intestinal barrier, regulating immunity, and correcting bacterial imbalances. Participants are randomly assigned to receive either Live SK08 powder or a matching placebo powder, both taken orally twice daily for up to 52 weeks. The study is double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo. Before treatment, participants undergo a run-in period with symptom monitoring, and colonoscopy results must meet specific criteria. The study includes continuous monitoring for up to one year. During the trial, participants will complete diaries to record symptoms such as abdominal pain, stool consistency, and bloating. Researchers will assess weekly responders, symptom relief scales, and quality of life scores up to 52 weeks. Safety will be monitored by tracking adverse events. Participants agree to maintain their usual diet and lifestyle throughout the study and attend scheduled visits for evaluations and laboratory tests.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and able to follow study procedures including diary completion
- Age between 18 and 70 years old, any gender
- Diagnosed with IBS-D per Rome IV criteria, with symptoms lasting at least 6 months
- Colonoscopy completed within 12 months before study with acceptable findings
- Colonoscopy or endoscopy at least 4 weeks before run-in period with ongoing IBS symptoms
- During run-in, average of 4 or more days per week with loose stools and abdominal pain score of 3 or higher on those days
- Completed symptom diary as required before randomization
- No use of relief or pain medications in the 14 days prior to randomization
- Agree to maintain usual diet and lifestyle during the study period
You will not qualify if you...
- Having constipation-predominant, mixed, or unclassified IBS
- Presence of organic gastrointestinal diseases beyond mild gastritis or polyps as defined
- Digestive system diseases like pancreatitis, cirrhosis, or symptomatic gallstones
- Known lactose intolerance or celiac disease
- Serious systemic diseases including heart, lung, kidney conditions, cancer, autoimmune or metabolic diseases
- History of abdominal or pelvic surgery except specified minor procedures
- Psychiatric disorders requiring medication or moderate to severe depression or anxiety
- Clinically significant positive fecal occult blood or white blood cells
- Positive for hepatitis C, HIV, syphilis, or hepatitis B requiring treatment
- Significant abnormal lab tests that may affect safety
- History of drug or alcohol abuse
- Unable to swallow oral solid dosage forms even with liquids
- Allergy to study drug or rescue medications
- Use of drugs affecting gastrointestinal function that cannot be stopped during the trial
- Pregnancy or breastfeeding
- Inability or unwillingness to use reliable contraception if applicable
- Participation in other clinical trials or previous SK08 study as specified
- Investigator judgment that participant is unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants complete symptom diaries and maintain usual diet and lifestyle while monitoring symptoms to confirm eligibility before randomization.
Regular diary completion before randomization
Duration - Up to 52 weeks
Participants receive either Live SK08 powder or placebo orally twice daily to evaluate efficacy and safety for IBS-D symptoms.
Regular visits throughout treatment period
Trial Site Locations
Total: 2 locations
1
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
Actively Recruiting
2
Binzhou Medical University Hospital
Binzhou, Shandong, China, 256603
Actively Recruiting
Research Team
Y
Yangyang Liu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here