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The Effect of a Probiotic Strain on Aspirin-induced GI Damage

NCT03910322 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-26

No results posted yet for this study

Summary

The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years.

Conditions

  • Reduction of Small Intestinal Ulceration Risk

Interventions

DIETARY_SUPPLEMENT

Bif195

Two different doses of the bacterial strain Bif195 is compared to placebo

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • 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
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2019-12-01
Completion
2019-12-01

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 NCT03910322 on ClinicalTrials.gov