Clinical study carried out to investigate the efficacy of two probiotic formulates on irritable bowel syndrome
Completed
- Conditions
- Irritable bowel syndrome associated constipation (IBS-C)Digestive System
- Registration Number
- ISRCTN15032219
- Lead Sponsor
- Farcoderm S.R.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. Aged between 18 and 65 years old
2. Suffering from Irritable Bowel Syndrome with constipation (IBS-C)
Exclusion Criteria
1. Pregnancy or intention to become pregnant during the study period
2. Lactation
3. Food intolerances/allergy
4. Known history of gastro-intestinal disorders
5. Chronic or acute gastrointestinal disorders
6. Participation in another similar study
7. Unwillingness or inability to comply with the study protocol requirements
8. Currently using food supplements or drugs containing actives having an influence on gastro-intestinal physiology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. IBS-C symptoms are measured using the IBS-C questionnaire of related symptoms, which consists of five items (bloating, abdominal pain, constipation, abdominal cramps and flatulence) scored on a 10-point Visual Analogue Scale (VAS) at baseline, 10, 30 and 60 days<br>2. Gut colonization is determined through fecal microbiological analyses using species-specific qPCR on stool samples collected at baseline, 10, 30 and 60 days
- Secondary Outcome Measures
Name Time Method Maintenance of the obtained effects are measured using IBS-C symptoms questionnaire microbiological analyses performed by species-specific qPCR 30 days after the last product(s) intake.