NCT02189707 - Effects of Probiotic Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Constipation. | Biotech Hunter

Enrollment

228

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions

ConstipationGastrointestinal Disorder

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.

Trial Locations (1)

38610

EUROFINS OPTIMED Clinical Research, Gières