Side Effects of Acetylsalicylic Acid Use Clinical Trial
— PIP-DOfficial 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.
| Verified date | May 2018 |
| Source | Chr Hansen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | April 4, 2018 |
| Est. primary completion date | December 21, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Atlantia Food Clnical Trials | Cork |
| Lead Sponsor | Collaborator |
|---|---|
| Chr Hansen | Atlantia Food Clinical Trials |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | 8 weeks | |
| Secondary | 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). | 8 weeks | |
| Secondary | 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). | 8 weeks | |
| Secondary | Blood I-FABP concentration | 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. | 8 weeks | |
| Secondary | 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). | 8 weeks | |
| Secondary | Mucosal red spots 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 red spot number between Visit 2 (randomization) and Visit 7 (end of treatment). | 8 weeks | |
| Secondary | Feces Calprotectin concentration. | 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. | 8 weeks | |
| Secondary | blood Calprotectin concentration | 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). | 8 weeks |