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

Study Overview
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Brief Summary
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The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years.

Detailed Description
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This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered. Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 visits. After having given their written informed consent, subjects will complete the 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 ASA and also be randomly assigned to 6-weeks daily intake of low or high-dose active (Bif195) or placebo product in a ratio of 1:1:1.

Official Title
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The Effect of Daily Intake of Two Different Doses of Bif195 on Small-intestinal Damage Induced by Acetylsalicylic Acid- a Randomized, Double-blind, Placebo-controlled, Three-armed, Parallel Group Trial in Healthy Volunteers.

Conditions
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Reduction of Small Intestinal Ulceration Risk

Intervention / Treatment
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* Dietary Supplement: Bif195
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Healthy and without any gastrointestinal discomfort/pain symptoms Age 40-60 years of both genders (aim of minimum 1/3 of each gender in each arm) Willing and able 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 ASA Resting diastolic blood pressure ≥ 95 mmHg Resting systolic blood pressure ≥ 150 mmHg A current diagnosis of psychiatric disease Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (ASA, 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 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 month 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 proton pump inhibitors within last 2 months prior to screening Use of immunosuppressant drugs within last 4 weeks prior to screening For Women: Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo arm. Similar trial product, but without Bif195 bacteria | Dietary Supplement: Placebo<br>* Placebo<br>|
| Experimental: Low-dose Bif195<br>Active trial product with minimum 15 billion CFU daily dose | Dietary Supplement: Bif195<br>* Two different doses of the bacterial strain Bif195 is compared to placebo<br>|
| Experimental: High-dose Bif195<br>Active trial product with minimum 50 billion CFU daily dose | Dietary Supplement: Bif195<br>* Two different doses of the bacterial strain Bif195 is compared to placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary endpoint - Lewis score high dose Bif195 vs Placebo | The effect of high-dose Bif195 versus placebo on small intestinal mucosal damage during a 6-week ASA challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment). | 6 weeks |