The Effect of a Probiotic Strain on Aspirin-induced GI Damage. (PIP-D)

Chr. Hansen

Status and phase

Completed

Phase 2

Conditions

Side Effects of Acetylsalicylic Acid Use

Treatments

Dietary Supplement: Placebo

Dietary Supplement: probiotic strain

Study type

Interventional

Funder types

Industry

Identifiers

NCT03228589

HND-GI-025

Details and patient eligibility

About

This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.

Full description

The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks, probiotic strain/placebo is given for two additional weeks to investigate the potential effects of the probiotic strain on intestinal healing after long-time Aspirin use.

Subjects will participate in the trial for a total duration of 10 weeks including the run-in phase. Besides the screening visit, the trial will consist of 6 visits.

After having given their written informed consent, subjects will complete 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 Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in a ratio of 1:1.

Enrollment

109 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Written informed consent
Healthy and without any gastrointestinal discomfort/pain symptoms
Age ≥ 18 - ≤ 40 years of both gender (aim of 1/3 of each gender in each arm)
Sedentary lifestyle (weekly training load below 2 hours within endurance sports)
Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial

Exclusion criteria

Abdominal surgery which, as judged by the investigator, might affect the GI function (except appendectomy and cholecystectomy)
History of peptic ulcer disease
Any known bleeding disorder
Allergy to Aspirin
History of H. pylori disease
Resting diastolic blood pressure ≥ 90 mmHg
Resting systolic blood pressure ≥ 140 mmHg
A current diagnosis of psychiatric disease
Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
BMI > 27
Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (Aspirin, Ibuprofen, Diclofenac, Naproxen, Celecoxib, Mefenamic acid, Etoricoxib, Indometacin)
Usage of medications, except contraceptives, in the last 2 weeks prior to screening
Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome
Lactose intolerance
Any other disease that, by the Investigators discretion, could interfere with the intestinal barrier function of the subject
Participation in other clinical trials in the past 2 months prior to screening
Regular use of probiotics in the last 2 months
Smoking and/or frequent use of other nicotine products
Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial
Use of laxatives, anti-diarrheals, anti-cholinergics and PPI within last 2 months prior to screening
Use of immunosuppressant drugs within last 4 weeks prior to screening
For Women: Pregnancy or lactation