Status:
COMPLETED
B. Lactis HN019 for Functional Constipation
Lead Sponsor:
Fonterra Research Centre
Collaborating Sponsors:
DuPont Nutrition and Health
Conditions:
Constipation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 symp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT01463293
Start Date
March 1 2012
End Date
May 1 2013
Last Update
July 24 2014
Active Locations (12)
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1
Arrowhead Family Health Center
Glendale, Arizona, United States, 85306
2
Diagnamics, Inc.
Encinitas, California, United States, 92024
3
Digestive & Liver Disease Specialists
Garden Grove, California, United States, 92840
4
StayWell Research
Northridge, California, United States, 91325