Clinical trial NCT01463293: B. Lactis HN019 for Functional Constipation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Keywords: constipation
probiotic
functional constipation
IBS-C
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
Collaborators: name: DuPont Nutrition and Health
First posted: 2011-11-01
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Whole Gut Transit Time
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient Assessment of Constipation Symptoms (PAC-SYM)
timeFrame: 4 weeks
measure: Patient Assessment of Constipation QoL (PAC-QoL)
timeFrame: 4 weeks
measure: Bowel Function Index
timeFrame: 4 weeks
measure: Adequate Relief of Constipation (Yes/no)
timeFrame: 4 weeks
measure: Bowel Movement Frequency
timeFrame: 4 weeks
measure: Stool Consistency
timeFrame: 4 weeks
measure: Overall Product Satisfaction
timeFrame: 4 weeks
measure: Adverse Event Frequency
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arrowhead Family Health Center
state: Arizona
city: Encinitas
country: United States
facility: Diagnamics, Inc.
state: California
city: Garden Grove
country: United States
facility: Digestive & Liver Disease Specialists
state: California
city: Northridge
country: United States
facility: StayWell Research
state: California
city: San Francisco
country: United States
facility: Sprim ALS
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Carrollton
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Discovery Clinical Trials South Main
state: Texas
city: Katy
country: United States
facility: Research Across America
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
Study officials:
affiliation: Capital Digestive Care, LLC
name: Robert Hardi, MD
role: PRINCIPAL_INVESTIGATOR
References: