The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage (PIP-I)

Chr. Hansen

Status: Completed

Conditions: Reduction of Small Intestinal Ulceration Risk

Treatments: Other: Placebo; Dietary Supplement: Bif195

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447924

HND-GI-038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

177 participants in 2 patient groups, including a placebo group

Placebo arm

Placebo Comparator group

Description:

Placebo arm. Similar trial product, but without Bif195 bacteria

Treatment:

Other: Placebo

Bif195 arm

Experimental group

Description:

Active trial product with minimum 15 billion CFU daily dose

Treatment:

Dietary Supplement: Bif195