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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-22

Study Completion Date

2021-06-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Reduction of Small Intestinal Ulceration Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo arm

Placebo arm. Similar trial product, but without Bif195 bacteria

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily intake of Placebo

Bif195 arm

Active trial product with minimum 15 billion CFU daily dose

Group Type EXPERIMENTAL

Bif195

Intervention Type DIETARY_SUPPLEMENT

Daily intake of Bif195 dietary supplement

Interventions

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Bif195

Daily intake of Bif195 dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily intake of Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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