Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D
Led by Guangzhou Zhiyi Biotechnology Co., Ltd. · Updated on 2025-04-03
1298
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 comply with study procedures, including diary completion
- Age between 18 and 70 years old (inclusive)
- Diagnosed IBS-D with symptoms meeting Rome IV criteria for at least 6 months
- Completed colonoscopy within 12 months before run-in period with acceptable findings
- Colonoscopy or endoscopy done at least 4 weeks before run-in period with ongoing IBS symptoms
- During run-in, average of 4 or more days per week with type 6 or 7 stool and abdominal pain score of 3 or more
- Completed diary at least 5 days in the week before randomization and at least 10 days in the 2 weeks before randomization
- No use of relief drugs or analgesics within 14 days prior to randomization
- Agree to maintain usual diet and lifestyle throughout the study
You will not qualify if you...
- Patients with constipated, mixed, or amorphous IBS
- Organic gastrointestinal diseases except certain mild gastritis
- Serious digestive diseases like tuberculous peritonitis, pancreatitis, cirrhosis, biliary diseases (except mild fatty liver or asymptomatic gallstones)
- Known lactose intolerance or celiac disease
- Serious systemic diseases including heart, lung, kidney, malignant tumors, autoimmune, metabolic, or reproductive system diseases
- History of abdominal or pelvic surgery except appendectomy, caesarean section, tubal ligation without complications, or hernia repair
- Diagnosed psychiatric disorders or moderate to severe depression or anxiety needing medication
- Positive fecal occult blood or white blood cells judged clinically significant
- Positive for hepatitis C, HIV, syphilis, or hepatitis B requiring antiviral therapy
- Significant lab abnormalities affecting safety
- History of drug or alcohol abuse
- Unable to take oral solid dosage forms even with liquids
- Allergy to study or rescue drugs or ingredients
- Use of drugs affecting gastrointestinal function that cannot be stopped
- Pregnant or breastfeeding women
- Unable or unwilling to use reliable contraception or planning pregnancy
- Participation in clinical trials using experimental drugs/devices within 3 months
- Previous participation in SK08 clinical studies
- Investigator judgment deeming the participant unsuitable for the trial
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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