Clinical trial NCT03910322: The Effect of a Probiotic Strain on Aspirin-induced GI Damage
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Reduction of Small Intestinal Ulceration Risk
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2019-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: primary endpoint - Lewis score high dose Bif195 vs Placebo
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Atlantia Food Clinical Trials
state: Illinois
Study officials:
affiliation: Houston Methodist Gastroenterology Associates
name: Eamonn Quigley, Professor
role: PRINCIPAL_INVESTIGATOR
References: