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The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage (PIP-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447924
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Chr Hansen

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.

Condition or disease Intervention/treatment Phase
Reduction of Small Intestinal Ulceration Risk Dietary Supplement: Bif195 Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Placebo Comparator: Placebo arm
Placebo arm. Similar trial product, but without Bif195 bacteria
Other: Placebo
Daily intake of Placebo

Experimental: Bif195 arm
Active trial product with minimum 15 billion CFU daily dose
Dietary Supplement: Bif195
Daily intake of Bif195 dietary supplement




Primary Outcome Measures :
  1. Lewis score area-under-the-curve for Bif195 vs Placebo [ Time Frame: 6 weeks ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447924


Contacts
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Contact: Brynjulf Mortensen, PhD +45 51805488 dkbrmo@chr-hansen.com
Contact: Kevin O'Regan koregan@atlantiafoodtrials.com

Locations
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United States, Illinois
Atlantia Food Clinical Trials Recruiting
Chicago, Illinois, United States, 60611
Contact: Kevin O`Reagan       koregan@atlantiafoodtrials.com   
Sponsors and Collaborators
Chr Hansen
Investigators
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Principal Investigator: Eamonn Quigley, Professor Houston Methodist Gastroenterology Associates
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Responsible Party: Chr Hansen
ClinicalTrials.gov Identifier: NCT04447924    
Other Study ID Numbers: HND-GI-038
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ulcer
Pathologic Processes