Lactobacillus Reuteri in Adult With Functional Chronic Constipation

Catholic University, Italy

Status and phase: Completed; Phase 3

Conditions: Functional Constipation

Treatments: Drug: placebo; Drug: lactobacillus reuteri

Study type: Interventional

Funder types: Other

Identifiers

NCT01870700

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Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

lactobacillus reuteri

Experimental group

Description:

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.

Treatment:

Drug: lactobacillus reuteri

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo