NCT03910322

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

The Effect of Daily Intake of Two Different Doses of Bif195 on Small-intestinal Damage Induced by Acetylsalicylic Acid- a Randomized, Double-blind, Placebo-controlled, Three-armed, Parallel Group Trial in Healthy Volunteers.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chr Hansen · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA 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 300mg ASA and also be randomly assigned to 6-weeks daily intake of low or high-dose active (Bif195) or placebo product in a ratio of 1:1:1.

Conditions

• Reduction of Small Intestinal Ulceration Risk

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bif195	Two different doses of the bacterial strain Bif195 is compared to placebo
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2019-08-19
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-04-10
• Last updated: 2020-06-26

Locations

1 site across 1 country: United States