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Completed

NCT Number: NCT01870700

Lactobacillus Reuteri in Adult With Functional Chronic Constipation

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

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Key information

Conditions

Functional Constipation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Catholic University Sacred Heart

Rome, Italy/rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lactobacillus reuteri

Drug

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

Drug

a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks

Primary outcomes

  1. The increase of BMs/week frequency

    Time frame: January to June 2012 (up to 6 months)

Secondary outcomes

  1. the improvement of stool consistency

    Time frame: january to june 2012 (up to 6 months)

Sponsors and collaborators

Lead sponsor

Catholic University, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 6, 2013
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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