Status:
COMPLETED
The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
Lead Sponsor:
Chr Hansen
Conditions:
Reduction of Small Intestinal Ulceration Risk
Eligibility:
All Genders
18-40 years
Phase:
NA
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 health...
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 inta...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT04447924
Start Date
June 22 2020
End Date
June 10 2021
Last Update
August 26 2021
Active Locations (1)
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1
Atlantia Food Clinical Trials
Chicago, Illinois, United States, 60611