The Effect of a Probiotic Strain on Aspirin-induced GI Damage.
- Conditions
- Side Effects of Acetylsalicylic Acid Use
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: probiotic strain
- Registration Number
- NCT03228589
- Lead Sponsor
- Chr Hansen
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks. probiotic strain probiotic strain Active arm treated with the probiotic strain for 8 weeks.
- Primary Outcome Measures
Name Time Method Lewis score from capsule endoscopy 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 Outcome Measures
Name Time Method Mucosal ulcer number 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 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 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 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 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. 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 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).
Trial Locations
- Locations (1)
Atlantia Food Clnical Trials
🇮🇪Cork, Ireland