Clinical trial NCT03228589: The Effect of a Probiotic Strain on Aspirin-induced GI Damage.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Side Effects of Acetylsalicylic Acid Use
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2017-07-25
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aspirin challenge model
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lewis score from capsule endoscopy
timeFrame: 8 weeks
Secondary outcomes:
measure: Mucosal ulcer number
timeFrame: 8 weeks
measure: Pain module score of the GSRS questionnaire
timeFrame: 8 weeks
measure: Blood I-FABP concentration
timeFrame: 8 weeks
measure: Total score of the GSRS questionnaire
timeFrame: 8 weeks
measure: Mucosal red spots number
timeFrame: 8 weeks
measure: Feces Calprotectin concentration.
timeFrame: 8 weeks
measure: blood Calprotectin concentration
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clnical Trials
Study officials:
affiliation: GI Physiology Laboratory, Mercy University Hospital
name: Martin Buckley, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mortensen B, Murphy C, O'Grady J, Lucey M, Elsafi G, Barry L, Westphal V, Wellejus A, Lukjancenko O, Eklund AC, Nielsen HB, Baker A, Damholt A, van Hylckama Vlieg JET, Shanahan F, Buckley M. Bifidobacteriumbreve Bif195 Protects Against Small-Intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers. Gastroenterology. 2019 Sep;157(3):637-646.e4. doi: 10.1053/j.gastro.2019.05.008. Epub 2019 May 13.