Lactobacillus Reuteri in Adult With Functional Chronic Constipation

June 4, 2013 updated by: veronica ojetti, Catholic University, Italy

The Effect of Lactobacillus Reuteri Supplementation to Adult With Functional Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial

A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy/rome
      • Rome, Italy/rome, Italy, 00168
        • Catholic University Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: lactobacillus reuteri
Lactobacillus reuteri (DSM 17938) 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
Other Names:
  • Reuflor
Placebo Comparator: placebo
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
Drug: placebo
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The increase of BMs/week frequency
Time Frame: January to June 2012 (up to 6 months)
January to June 2012 (up to 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
the improvement of stool consistency
Time Frame: january to june 2012 (up to 6 months)
january to june 2012 (up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University, Italy

Investigators

  • Study Chair: veronica ojetti, Catholic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 25, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

June 6, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • no one

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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