Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
Phase 4
- Conditions
- Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
- Interventions
- Drug: placebo
- Registration Number
- NCT02614963
- Lead Sponsor
- Shandong University
- Brief Summary
Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- the presence of Rome III criteria for IBS ;
- Aged between 18 and 65 years old
Exclusion Criteria
- Antibiotic, probiotic or laxative usage within 4 weeks.
- organic gastrointestinal diseases
- Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
- pregnancy or lactation.
- previous major or complicated abdominal surgery.
- severe endometriosis and dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group placebo Irritable bowel syndrome patients treated with placebo Clostridium Butyricum group Clostridium Butyricum Irritable bowel syndrome patients treated with Clostridium Butyricum
- Primary Outcome Measures
Name Time Method the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores 7 months
- Secondary Outcome Measures
Name Time Method IBS patients'quality of life 7 months Quality of life was determined by using IBS-QOL scoring system for patients with IBS.
Composition of Microorganisms in stool 7 months Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China