Effects of Probiotic Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Constipation.
Condition: Constipation; Gastrointestinal Disorder
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Constipation
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Probiotic Bifidobacterium 1x1010 cfu; Probiotic Bifidobacterium 1x109 cfu; Placebo powder in capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): Probiotic powder (1 x1010 cfu B. lactis HN019) in capsules; Probiotic powder (1 x 109 cfu B. lactis HN019) in capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Gastrointestinal disorder; Constipation; Probiotics; Dietary supplement