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

Chr Hansen109 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

109

Conditions

Side Effects of Acetylsalicylic Acid Use

Interventions

probiotic strainDIETARY_SUPPLEMENT

8 weeks of treatment with probiotic strain

PlaceboDIETARY_SUPPLEMENT

8 weeks of treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Atlantia Food Clnical Trials

Cork, Ireland

Outcomes

Primary Outcomes

Lewis score from capsule endoscopy

The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy Lewis score between Visit 2 (randomization) and Visit 7 (end of treatment).

Time frame: 8 weeks

Secondary Outcomes

Mucosal ulcer number

The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal total ulcer number between Visit 2 (randomization) and Visit 7 (end of treatment).

Time frame: 8 weeks

Pain module score of the GSRS questionnaire

The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of pain module score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).

Time frame: 8 weeks

Blood I-FABP concentration

Time frame: 8 weeks

Total score of the GSRS questionnaire

The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of total score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).

Time frame: 8 weeks

Data from ClinicalTrials.gov

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