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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447924 on ClinicalTrials.gov