The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage (PIP-I)
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|ClinicalTrials.gov Identifier: NCT04447924|
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Reduction of Small Intestinal Ulceration Risk||Dietary Supplement: Bif195 Other: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Placebo arm
Placebo arm. Similar trial product, but without Bif195 bacteria
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
- 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).
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
|Contact: Brynjulf Mortensen, PhD||+45 email@example.com|
|Contact: Kevin O'Reganfirstname.lastname@example.org|
|United States, Illinois|
|Atlantia Food Clinical Trials||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Kevin O`Reagan email@example.com|
|Principal Investigator:||Eamonn Quigley, Professor||Houston Methodist Gastroenterology Associates|