Overview

This trial is active, not recruiting.

Condition constipation
Treatments b. lactis hn019, placebo
Phase phase 3
Sponsor Fonterra Research Centre
Collaborator Danisco
Start date March 2012
End date March 2013
Trial size 228 participants
Trial identifier NCT01463293, 11-SUS-02-FON-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Capsule containing 10 billion cfu B. lactis HN019
b. lactis hn019
Capsule containing 10 billion cfu B. lactis HN019 once a day
(Experimental)
Capsule containing 1 billion cfu B. lactis HN019
b. lactis hn019
Capsule containing 1 billion cfu B. lactis HN019 once a day
(Placebo Comparator)
Placebo capsule
placebo
Capsule containing no probiotic once a day

Primary Outcomes

Measure
Whole gut transit time
time frame: 4 weeks

Secondary Outcomes

Measure
Patient assessment of constipation symptoms (PAC-SYM)
time frame: 4 weeks
Patient assessment of constipation QoL (PAC-QoL)
time frame: 4 weeks
Bowel Function Index
time frame: 4 weeks
Adequate relief of constipation (yes/no)
time frame: 4 weeks
Bowel movement frequency
time frame: 4 weeks
Stool consistency
time frame: 4 weeks
Overall product satisfaction
time frame: 4 weeks
Adverse event frequency
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Age 18 to 70 years - Body mass index between 18.5 and 34.9 kg/m2 - Self-reported unsatisfactory defecation due to infrequent stools and/or difficult stool passage, which includes at least one of the following: symptoms of straining, difficulty expelling stool, a sense of incomplete evacuation, hard or lumpy stools, prolonged time to stool, or a need for manual maneuvers to pass stool. - Estimated stool consistency < 4.0 on BSSF (self-reported at screening) within the past month prior to enrollment. - Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects - Consent to the study and willing to comply with study product and methods Exclusion Criteria: - Major gastrointestinal complication (e.g. Crohn's disease, ulcer) - Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the subject or confound study results - Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness) - Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products - Non-laxative constipation medication use within 2 weeks of screening, laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study) - Daily use of anticholinergic agents, opioid analgesics, calcium supplements, calcium-channel blockers, and NSAIDs - Anticipated major dietary or exercise changes during the study - Systemic steroid use - Eating disorder - Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product) - History of alcohol, drug, or medication abuse - Pregnant or lactating female, or pregnancy planned during study period - Participation in another study with any investigational product within 30 days of screening - Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Additional Information

Official title 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
Principal investigator Robert Hardi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Fonterra Research Centre.