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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Reduction of Small Intestinal Ulceration Risk

In brief

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.

Key facts

Study ID

NCT03910322

Run by

Chr Hansen

People needed

30

Starts

2019-08-19

Expected to finish

2019-12-01

Last updated by the study team

2020-06-26

Who can join

Age: 40 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Atlantia Food Clinical Trials — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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