Lactobacillus Reuteri in Adult With Functional Chronic Constipation

NCT ID: NCT01870700

Last Updated: 2013-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

lactobacillus reuteri

Intervention Type 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

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Reuflor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic University, Italy

OTHER

Sponsor Role lead

Responsible Party

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veronica ojetti

adjunt professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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veronica ojetti

Role: STUDY_CHAIR

catholic university

Locations

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Catholic University Sacred Heart

Rome, Italy/rome, Italy

Site Status

Countries

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Italy

References

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Coccorullo P, Strisciuglio C, Martinelli M, Miele E, Greco L, Staiano A. Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. J Pediatr. 2010 Oct;157(4):598-602. doi: 10.1016/j.jpeds.2010.04.066. Epub 2010 Jun 12.

Reference Type BACKGROUND
PMID: 20542295 (View on PubMed)

Ojetti V, Ianiro G, Tortora A, D'Angelo G, Di Rienzo TA, Bibbo S, Migneco A, Gasbarrini A. The effect of Lactobacillus reuteri supplementation in adults with chronic functional constipation: a randomized, double-blind, placebo-controlled trial. J Gastrointestin Liver Dis. 2014 Dec;23(4):387-91. doi: 10.15403/jgld.2014.1121.234.elr.

Reference Type DERIVED
PMID: 25531996 (View on PubMed)

Other Identifiers

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no one

Identifier Type: -

Identifier Source: org_study_id

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