B. Lactis HN019 for Functional Constipation (CTT)

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

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 Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: B. lactis HN019; Dietary supplement: B. lactis HN019; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arrowhead Family Health Center
  • California
    • Encinitas, California, United States, 92024
      • Diagnamics, Inc.
    • Garden Grove, California, United States, 92840
      • Digestive & Liver Disease Specialists
    • Northridge, California, United States, 91325
      • Staywell Research
    • San Francisco, California, United States, 94109
      • Sprim ALS
    • Westlake Village, California, United States, 91361
      • Westlake Medical Research
  • Texas
    • Carrollton, Texas, United States, 75010
      • Research Across America
    • Dallas, Texas, United States, 77054
      • Research Across America
    • Houston, Texas, United States, 77025
      • Discovery Clinical Trials South Main
    • Katy, Texas, United States, 77450
      • Research Across America
    • Plano, Texas, United States, 75024
      • Village Health Partners
    • Plano, Texas, United States, 75093
      • North Texas Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsule	Dietary supplement: Placebo; Capsule containing no probiotic once a day
Experimental: High-dose probiotic; Capsule containing 10 billion cfu B. lactis HN019	Dietary supplement: B. lactis HN019; Capsule containing 10 billion cfu B. lactis HN019 once a day; Dietary supplement: B. lactis HN019; Capsule containing 1 billion cfu B. lactis HN019 once a day
Experimental: Low dose probiotic; Capsule containing 1 billion cfu B. lactis HN019	Dietary supplement: B. lactis HN019; Capsule containing 10 billion cfu B. lactis HN019 once a day; Dietary supplement: B. lactis HN019; Capsule containing 1 billion cfu B. lactis HN019 once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Bowel Movement Frequency	Subjects will record the number of defecations per day in a diary.	4 weeks
Stool Consistency	Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form	4 weeks
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
Adverse Event Frequency	All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.	4 weeks

Collaborators and Investigators

• Sponsor: Fonterra Research Centre
• Collaborators: DuPont Nutrition and Health
• Investigators: Principal Investigator: Robert Hardi, MD, Capital Digestive Care, LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: probiotic; constipation; IBS-C; functional constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 11-SUS-02-FON-02