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

C

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

109 participants in 2 patient groups, including a placebo group

probiotic strain
Experimental group
Description:
Active arm treated with the probiotic strain for 8 weeks.
Treatment:
Dietary Supplement: probiotic strain
Placebo
Placebo Comparator group
Description:
Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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