B. Lactis HN019 for Functional Constipation

Constipation Clinical Trial

— CTT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463293
• Other study ID #: 11-SUS-02-FON-02
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2011
• Last updated: June 26, 2014
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Fonterra Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• B. lactis HN019
Capsule containing 10 billion cfu B. lactis HN019 once a day
• B. lactis HN019
Capsule containing 1 billion cfu B. lactis HN019 once a day
• Placebo
Capsule containing no probiotic once a day

Locations

Country	Name	City	State
United States	Research Across America	Carrollton	Texas
United States	Research Across America	Dallas	Texas
United States	Diagnamics, Inc.	Encinitas	California
United States	Digestive & Liver Disease Specialists	Garden Grove	California
United States	Arrowhead Family Health Center	Glendale	Arizona
United States	Discovery Clinical Trials South Main	Houston	Texas
United States	Research Across America	Katy	Texas
United States	StayWell Research	Northridge	California
United States	North Texas Family Medicine	Plano	Texas
United States	Village Health Partners	Plano	Texas
United States	Sprim ALS	San Francisco	California
United States	Westlake Medical Research	Westlake Village	California

Sponsors (2)

Lead Sponsor	Collaborator
Fonterra Research Centre	DuPont Nutrition and Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Gut Transit Time	The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28	4 weeks	No
Secondary	Patient Assessment of Constipation Symptoms (PAC-SYM)	The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.	4 weeks	No
Secondary	Patient Assessment of Constipation QoL (PAC-QoL)	The PAC-QoL is a 28-question survey that asks questions on their quality of life.	4 weeks	No
Secondary	Bowel Function Index	The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.	4 weeks	No
Secondary	Adequate Relief of Constipation (Yes/no)	Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.	4 weeks	No
Secondary	Bowel Movement Frequency	Subjects will record the number of defecations per day in a diary.	4 weeks	No
Secondary	Stool Consistency	Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form	4 weeks	No
Secondary	Overall Product Satisfaction	At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale	4 weeks	No
Secondary	Adverse Event Frequency	All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.	4 weeks	Yes