NCT01463293

B. Lactis HN019 for Functional Constipation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Fonterra Research Centre · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the effects of 4-week probiotic supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.

Detailed description

This prospective, double-blind, randomized, placebo-controlled clinical trial will investigate the effects of 4-week B. lactis HN019 supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation. Participants who meet all study entry criteria will enter a 2-week run-in period. Following successful completion of the run-in period, subjects will be randomized to 4-week supplementation with B. lactis HN019 (10 billion cfu), B. lactis HN019 (1 billion cfu), or placebo. The primary outcome of whole gut transit time will be evaluated with abdominal x-rays on days 0 and 28. Secondary outcomes include IBS-specific questionnaires (administered on days 0 and 28); abdominal pain severity, bowel movement frequency, stool consistency, and adverse events (evaluated daily throughout the study); and overall product satisfaction (evaluated at day 28). Physical activity questionnaires and 24-hour food recalls will be completed periodically during the trial.

Conditions

• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B. lactis HN019	Capsule containing 10 billion cfu B. lactis HN019 once a day
DIETARY_SUPPLEMENT	B. lactis HN019	Capsule containing 1 billion cfu B. lactis HN019 once a day
DIETARY_SUPPLEMENT	Placebo	Capsule containing no probiotic once a day

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2011-11-01
• Last updated: 2014-07-24
• Results posted: 2014-07-24

Locations

12 sites across 1 country: United States