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

Reduction of Small Intestinal Ulceration Risk Clinical Trial

— PIP-I  

Official title:

The Effect of Daily Intake of Bifidobacterium Breve Bif195 on Small-intestinal Damage Induced by Ibuprofen - a Randomized, Double-blind, Placebo-controlled Trial in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447924
• Other study ID #: HND-GI-038
• Status: Completed
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: August 2021
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Reduction of Small Intestinal Ulceration Risk
• Ulcer

Intervention

Dietary Supplement:
• Bif195
Daily intake of Bif195 dietary supplement

Other:
• Placebo
Daily intake of Placebo

Locations

Country	Name	City	State
United States	Atlantia Food Clinical Trials	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Chr Hansen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lewis score area-under-the-curve for Bif195 vs Placebo	The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).	6 weeks