Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Clostridium Butyricum
Brief summary
Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome
Interventions
Irritable bowel syndrome patients treated with Clostridium Butyricum
DRUGplacebo
Irritable bowel syndrome patients treated with placebo
Sponsors
Linyi People's Hospital
Taian City Central Hospital
Qingdao Eastsea Pharmaceutical Co., Ltd.
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores | 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
Primary ContactLi Yanqing, MD,PhD
Outcome results
None listed