Lactobacillus Reuteri in Adult With Functional Chronic Constipation
Phase 3
Completed
- Conditions
- Functional Constipation
- Interventions
- Drug: placebo
- Registration Number
- NCT01870700
- Lead Sponsor
- Catholic University, Italy
- Brief Summary
A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.
- Detailed Description
Patients affected by functional constipation according to Rome III criteria. The increase of Bowel Movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- functional constipation rome III
Exclusion Criteria
- hypothyroidism or other metabolic or renal abnormalities, or
- antibiotic's treatment,
- probiotic or prebiotic supplementation in the last month
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lactobacillus reuteri lactobacillus reuteri Intervention: supplementation with the probiotic Lactobacillus reuteri (DSM 17938),Reuflor, was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks. placebo placebo a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
- Primary Outcome Measures
Name Time Method The increase of BMs/week frequency January to June 2012 (up to 6 months)
- Secondary Outcome Measures
Name Time Method the improvement of stool consistency january to june 2012 (up to 6 months)
Trial Locations
- Locations (1)
Catholic University Sacred Heart
🇮🇹Rome, Italy/rome, Italy