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Effects of Probiotic Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Constipation.

NCT02189707 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2015-05-07

No results posted yet for this study

Summary

To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic Bifidobacterium 1x1010 cfu

Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks.

DIETARY_SUPPLEMENT

Probiotic Bifidobacterium 1x109 cfu

Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day.

OTHER

Placebo powder in capsules

Participants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks.

Sponsors & Collaborators

  • Eurofins Optimed

    collaborator INDUSTRY

  • Danisco Sweeteners Oy

    lead INDUSTRY

Principal Investigators

  • Mathilde Latreille-Barbier, MD · Eurofins Optimed

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02189707 on ClinicalTrials.gov