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B. Lactis HN019 for Functional Constipation (CTT)

Primary Purpose

Constipation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
B. lactis HN019
B. lactis HN019
Placebo
Sponsored by
Fonterra Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, probiotic, functional constipation, IBS-C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arrowhead Family Health Center
  • Diagnamics, Inc.
  • Digestive & Liver Disease Specialists
  • StayWell Research
  • Sprim ALS
  • Westlake Medical Research
  • Research Across America
  • Research Across America
  • Discovery Clinical Trials South Main
  • Research Across America
  • Village Health Partners
  • North Texas Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High-dose probiotic

Low dose probiotic

Placebo

Arm Description

Capsule containing 10 billion cfu B. lactis HN019

Capsule containing 1 billion cfu B. lactis HN019

Placebo capsule

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Patient Assessment of Constipation QoL (PAC-QoL)
The PAC-QoL is a 28-question survey that asks questions on their quality of life.
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.
Adequate Relief of Constipation (Yes/no)
Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.
Bowel Movement Frequency
Subjects will record the number of defecations per day in a diary.
Stool Consistency
Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form
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
Adverse Event Frequency
All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.

Full Information

First Posted
October 28, 2011
Last Updated
June 26, 2014
Sponsor
Fonterra Research Centre
Collaborators
DuPont Nutrition and Health
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1. Study Identification

Unique Protocol Identification Number
NCT01463293
Brief Title
B. Lactis HN019 for Functional Constipation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fonterra Research Centre
Collaborators
DuPont Nutrition and Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, probiotic, functional constipation, IBS-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-dose probiotic
Arm Type
Experimental
Arm Description
Capsule containing 10 billion cfu B. lactis HN019
Arm Title
Low dose probiotic
Arm Type
Experimental
Arm Description
Capsule containing 1 billion cfu B. lactis HN019
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
B. lactis HN019
Intervention Description
Capsule containing 10 billion cfu B. lactis HN019 once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
B. lactis HN019
Intervention Description
Capsule containing 1 billion cfu B. lactis HN019 once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Capsule containing no probiotic once a day
Primary Outcome Measure Information:
Title
Whole Gut Transit Time
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient Assessment of Constipation Symptoms (PAC-SYM)
Description
The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.
Time Frame
4 weeks
Title
Patient Assessment of Constipation QoL (PAC-QoL)
Description
The PAC-QoL is a 28-question survey that asks questions on their quality of life.
Time Frame
4 weeks
Title
Bowel Function Index
Description
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.
Time Frame
4 weeks
Title
Adequate Relief of Constipation (Yes/no)
Description
Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.
Time Frame
4 weeks
Title
Bowel Movement Frequency
Description
Subjects will record the number of defecations per day in a diary.
Time Frame
4 weeks
Title
Stool Consistency
Description
Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form
Time Frame
4 weeks
Title
Overall Product Satisfaction
Description
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
Time Frame
4 weeks
Title
Adverse Event Frequency
Description
All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hardi, MD
Organizational Affiliation
Capital Digestive Care, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arrowhead Family Health Center
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Diagnamics, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Digestive & Liver Disease Specialists
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
StayWell Research
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Sprim ALS
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Research Across America
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Discovery Clinical Trials South Main
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Research Across America
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Village Health Partners
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
North Texas Family Medicine
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

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B. Lactis HN019 for Functional Constipation

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