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B. Lactis HN019 for Functional Constipation (CTT)

This study has been completed.
Sponsor:
Collaborator:
DuPont Nutrition and Health
Information provided by (Responsible Party):
Fonterra Research Centre
ClinicalTrials.gov Identifier:
NCT01463293
First received: October 28, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

This study will investigate the effects of 4-week probiotic supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.


Condition Intervention Phase
Constipation
Dietary Supplement: B. lactis HN019
Dietary Supplement: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Fonterra Research Centre:

Primary Outcome Measures:
  • Whole Gut Transit Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Patient Assessment of Constipation Symptoms (PAC-SYM) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.

  • Patient Assessment of Constipation QoL (PAC-QoL) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The PAC-QoL is a 28-question survey that asks questions on their quality of life.

  • Bowel Function Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Adequate Relief of Constipation (Yes/no) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.

  • Bowel Movement Frequency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects will record the number of defecations per day in a diary.

  • Stool Consistency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form

  • Overall Product Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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

  • Adverse Event Frequency [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.


Enrollment: 224
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Low dose probiotic
Capsule containing 1 billion cfu B. lactis HN019
Dietary Supplement: B. lactis HN019
Capsule containing 1 billion cfu B. lactis HN019 once a day
Placebo Comparator: Placebo
Placebo capsule
Dietary Supplement: Placebo
Capsule containing no probiotic once a day

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463293

Locations
United States, Arizona
Arrowhead Family Health Center
Glendale, Arizona, United States, 85306
United States, California
Diagnamics, Inc.
Encinitas, California, United States, 92024
Digestive & Liver Disease Specialists
Garden Grove, California, United States, 92840
StayWell Research
Northridge, California, United States, 91325
Sprim ALS
San Francisco, California, United States, 94109
Westlake Medical Research
Westlake Village, California, United States, 91361
United States, Texas
Research Across America
Carrollton, Texas, United States, 75010
Research Across America
Dallas, Texas, United States, 77054
Discovery Clinical Trials South Main
Houston, Texas, United States, 77025
Research Across America
Katy, Texas, United States, 77450
North Texas Family Medicine
Plano, Texas, United States, 75093
Village Health Partners
Plano, Texas, United States, 75024
Sponsors and Collaborators
Fonterra Research Centre
DuPont Nutrition and Health
Investigators
Principal Investigator: Robert Hardi, MD Capital Digestive Care, LLC
  More Information

No publications provided

Responsible Party: Fonterra Research Centre
ClinicalTrials.gov Identifier: NCT01463293     History of Changes
Other Study ID Numbers: 11-SUS-02-FON-02
Study First Received: October 28, 2011
Results First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fonterra Research Centre:
constipation
probiotic
functional constipation
IBS-C

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014