NCT02189707

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

Effects of 4-week Bifidobacterium-lactis HN019 Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Danisco Sweeteners Oy · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence in the general population of 12-19%, which results in lower quality of life and significant healthcare costs to the individual. Almost 9 in 10 physician visits for constipation result in a laxative prescription. Additionally, consumers in the USA and in the United Kingdom spend almost 1 billion dollars annually for over-the-counter laxatives. Chronic constipation is diagnosed almost solely on patient symptoms, which generally includes unsatisfactory defecation due to infrequent stools, difficult stool passage, or both. The cause of chronic constipation is unknown and likely multifactorial with physiological changes, psychological factors, and lifestyle influences identified as possible culprits. Consequently, identification of effective constipation treatments remains a challenge. The initial management of constipation symptoms is focused on evaluating lifestyle and diet variables as possible culprits. If lifestyle modifications are unsuccessful in alleviating constipation, various medications may be prescribed. In fact, about 50% of adults with constipation are not completely satisfied with available treatments. Consequently, there is a clear need for alternative constipation treatments that are safe, effective, and cost-effective. Probiotics are live micro-organisms that result in a health benefit for the host when administered in adequate dosages. In recent years, probiotics have been commonly used to alleviate symptoms in a variety of gastrointestinal disorders. It is hypothesized that probiotics help to maintain gut lumen homeostasis by hindering growth of luminal pathogens and restoring the normal flora of the gut. As such, the use of probiotics for the relief of constipation symptoms is very promising. Numerous studies have been published addressing the utility of probiotics for gastrointestinal health including constipation. However, since probiotic efficacy is largely strain-specific, each specific strain must be individually tested in clinical trials. Given the promising clinical results of probiotics on gastrointestinal health to date, the objective of this clinical trial is to evaluate the safety and effectiveness of 4-week Bifidobacterium lactis HN019 supplementation, in a dose-ranging fashion, on Colonic Transit Time (CTT) and gastrointestinal symptoms in adults with constipation.

Conditions

• Constipation
• Gastrointestinal Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-07-14
• Last updated: 2015-05-07

Locations

1 site across 1 country: France