Completed

NCT Number: NCT03228589

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

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.

Completed

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Key information

Conditions

Side Effects of Acetylsalicylic Acid Use

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Atlantia Food Clnical Trials

Cork, T23 R50R, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic strain

Dietary Supplement

8 weeks of treatment with probiotic strain

Placebo

Dietary Supplement

8 weeks of treatment

Primary outcomes

Lewis score from capsule endoscopy

Time frame: 8 weeks

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).

Secondary outcomes

Mucosal ulcer number

Time frame: 8 weeks

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).
Pain module score of the GSRS questionnaire

Time frame: 8 weeks

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).
Blood I-FABP concentration

Time frame: 8 weeks

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 for Visit 2-Visit 7 blood I-FABP concentration.
Total score of the GSRS questionnaire

Time frame: 8 weeks

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).
Mucosal red spots number

Time frame: 8 weeks

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 red spot number between Visit 2 (randomization) and Visit 7 (end of treatment).
Feces Calprotectin concentration.

Time frame: 8 weeks

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 for Visit 2-Visit 7 feces Calprotectin concentration.
blood Calprotectin concentration

Time frame: 8 weeks

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 blood Calprotectin concentration between Visit 2 (randomization) and Visit 7 (end of treatment).

Sponsors and collaborators

Lead sponsor

Chr Hansen

Industry

Collaborators

Atlantia Food Clinical Trials

Registry information

Official study title

The Effect of 8 Weeks Intake of a Probiotic Strain on a 6 Week Aspirin-induced Intestinal Deterioration Challenge in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled, Two Armed, Parallel Group Trial.

Acronym: PIP-D

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Jul 25, 2017
Registry last updated: May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.