Status:
COMPLETED
The Effect of a Probiotic Strain on Aspirin-induced GI Damage.
Lead Sponsor:
Chr Hansen
Collaborating Sponsors:
Atlantia Food Clinical Trials
Conditions:
Side Effects of Acetylsalicylic Acid Use
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
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 prob...
Detailed 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 strai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2018
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03228589
Start Date
July 15 2017
End Date
April 4 2018
Last Update
May 3 2018
Active Locations (1)
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1
Atlantia Food Clnical Trials
Cork, Ireland, T23 R50R