At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
B. lactis HN019 +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating B. lactis HN019 and Placebo for Constipation. Completed, enrolled 224 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
CollaboratorsDuPont Nutrition and Health
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartMar 2012
Primary CompletionMar 2013
Study CompletionMay 2013
TodayJul 2026
First PostedNov 1, 2011
Enrollment StartMar 1, 2012
Primary CompletionMar 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.7 years ago
Interventions
B. lactis HN019dietary
Capsule containing 10 billion cfu B. lactis HN019 once a day
B. lactis HN019dietary
Capsule containing 1 billion cfu B. lactis HN019 once a day
Placebodietary
Capsule containing no probiotic once a day