B. Lactis HN019 for Functional Constipation

NCT01463293 | Completed Phase 3 Results

• 1 other identifier: 11-SUS-02-FON-02
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 12

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.

Conditions

Constipation

Keywords

constipation; probiotic; functional constipation; IBS-C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Patient Assessment of Constipation Symptoms (PAC-SYM)

  4 weeks

• Patient Assessment of Constipation QoL (PAC-QoL)

  4 weeks

• Bowel Function Index

  4 weeks

• Adequate Relief of Constipation (Yes/no)

  4 weeks

• Bowel Movement Frequency

  4 weeks

Study Arms (3)

High-dose probiotic

EXPERIMENTAL

Capsule containing 10 billion cfu B. lactis HN019

Dietary Supplement: B. lactis HN019

Low dose probiotic

EXPERIMENTAL

Capsule containing 1 billion cfu B. lactis HN019

Dietary Supplement: B. lactis HN019

Placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Placebo

Interventions

B. lactis HN019 DIETARY_SUPPLEMENT

Capsule containing 10 billion cfu B. lactis HN019 once a day

High-dose probiotic

Placebo DIETARY_SUPPLEMENT

Capsule containing no probiotic once a day

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fonterra Research Centre: lead
• DuPont Nutrition and Health: collaborator

Study Sites (12)

Arrowhead Family Health Center

Glendale, Arizona, 85306, United States

Location

Diagnamics, Inc.

Encinitas, California, 92024, United States

Location

Digestive & Liver Disease Specialists

Garden Grove, California, 92840, United States

Location

StayWell Research

Northridge, California, 91325, United States

Location

Sprim ALS

San Francisco, California, 94109, United States

Location

Westlake Medical Research

Westlake Village, California, 91361, United States

Location

Research Across America

Carrollton, Texas, 75010, United States

Location

Research Across America

Dallas, Texas, 77054, United States

Location

Discovery Clinical Trials South Main

Houston, Texas, 77025, United States

Location

Research Across America

Katy, Texas, 77450, United States

Location

Village Health Partners

Plano, Texas, 75024, United States

Location

North Texas Family Medicine

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

A substantial number of protocol violations occurred for the primary end-point. Only 39 out of 224 subjects consumed sufficent radio-opaque markers for baseline and post-intervention transit time.Therefore, the study failed to yield evaluable data.

Results Point of Contact

• Title: Dr James Dekker
• Organization: Fonterra Research Centre

james.dekker@fonterra.com

+64 6 350 6323

Study Officials

• Robert Hardi, MD

  Capital Digestive Care, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 1, 2011
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 24, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-06

Locations

US (12)