Lactobacillus Reuteri in Adult With Functional Chronic Constipation

Phase 3

Completed

• Conditions: Functional Constipation
• Interventions: Drug: lactobacillus reuteri; 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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2013-05-25
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-06
• Last Update Posted: 2013-06-06

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