Back to resultsThe Effect of a Probiotic Strain on Ibuprofen-induced GI Damage (PIP-I)
Primary Purpose
Reduction of Small Intestinal Ulceration Risk
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bif195
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Reduction of Small Intestinal Ulceration Risk
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Healthy and without any gastrointestinal pain or other significant symptoms
- Age 18 - 40 years
- Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
Exclusion Criteria:
-
Sites / Locations
- Atlantia Food Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo arm
Bif195 arm
Arm Description
Placebo arm. Similar trial product, but without Bif195 bacteria
Active trial product with minimum 15 billion CFU daily dose
Outcomes
Primary Outcome Measures
Lewis score area-under-the-curve for Bif195 vs Placebo
The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04447924
Brief Title
The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
Acronym
PIP-I
Official Title
The Effect of Daily Intake of Bifidobacterium Breve Bif195 on Small-intestinal Damage Induced by Ibuprofen - a Randomized, Double-blind, Placebo-controlled Trial in Healthy Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chr Hansen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule endoscopy in a healthy US population.
Detailed Description
This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to daily intake of 800mg of Ibuprofen.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and Ibuprofen is co-administered.
Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 visits.
After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. After baseline assessments at Visit 2, subjects will start daily intake of 800mg of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo product in a ratio of 1:1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction of Small Intestinal Ulceration Risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo arm. Similar trial product, but without Bif195 bacteria
Arm Title
Bif195 arm
Arm Type
Experimental
Arm Description
Active trial product with minimum 15 billion CFU daily dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Bif195
Intervention Description
Daily intake of Bif195 dietary supplement
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Daily intake of Placebo
Primary Outcome Measure Information:
Title
Lewis score area-under-the-curve for Bif195 vs Placebo
Description
The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Healthy and without any gastrointestinal pain or other significant symptoms
Age 18 - 40 years
Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eamonn Quigley, Professor
Organizational Affiliation
Houston Methodist Gastroenterology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlantia Food Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
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