The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
NCT04447924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177
Last updated 2021-08-26
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.
Conditions
- Reduction of Small Intestinal Ulceration Risk
Interventions
- DIETARY_SUPPLEMENT
-
Bif195
Daily intake of Bif195 dietary supplement
- OTHER
-
Placebo
Daily intake of Placebo
Sponsors & Collaborators
-
Chr Hansen
lead INDUSTRY
Principal Investigators
-
Eamonn Quigley, Professor · Houston Methodist Gastroenterology Associates
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-06-22
- Primary Completion
- 2021-06-10
- Completion
- 2021-06-10
Countries
- United States
Study Locations
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