The effect of daily intake of two different doses of Bifidobacterium Breve Bif195 on small-intestinal damage induced by Acetlysalicylic Acid- a randomized, double-blind, placebo-controlled, three-armed, parallel group trial in healthy volunteers.

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

Non-Steroidal-Anti-Inflammatory Drugs (NSAIDs), such as Aspirin, are commonly used worldwide, both as prescription-only medicines and as “over-the-counter” medications. They are often used in the treatment of many common pain-related conditions, including headaches and menstrual pain, and for long-term treatment of chronic inflammatory diseases, including osteoarthritis and rheumatoid arthritis. Long-term use of low-dose NSAIDS are also recommended and prescribed for their heart-protecting properties. 

However, low dose use of NSAIDS, such as Aspirin, is associated with damage to the stomach and intestines. The degree of damage depends on the dose of Aspirin, how it interacts with other medications and other patient risk factors.  Aspirin has emerged as one of the most common causes of peptic ulcer bleeding in developed countries and is associated with a significant increased risk of upper gastrointestinal (GI) bleeding and ulcers. 

Live bacteria formulated as probiotics may offer a safe alternative to prevent negative side effects of NSAIDS, such as Aspirin. Probiotic bacteria have been demonstrated to have possible healing effects against intestinal inflammation and among long-term Aspirin users. 

 

Description

We will measure the damage in your intestine using Video Capsule Endoscopy (VCE). Capsule endoscopy uses a tiny wireless camera which sits inside a vitamin-size capsule you swallow. As the capsule travels through your digestive tract, the camera takes thousands of pictures that are transmitted to a recorder you wear on a belt around your waist.

The goal of the current clinical study is to explore the ability of the Bif195 to reduce and/or reverse Aspirin-induced small intestinal damage and GI symptoms in healthy volunteers. Thus, this study is one of many upcoming studies by Chr Hansen aiming at bringing a probiotic product to market that can aid in gastrointestinal side effects occurring with use of Aspirin.

 

Health check which includes a check on your heart and lungs, blood pressure check, BMI check and blood test. You will have 5 video capsule endoscopies completed during the trial and these will be reviewed by highly trained gastroenterologists. Any abnormal results/findings will be brought to your attention.

Details
Condition *Healthy Patient Studies
Clinical Study IdentifierTX225648
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy and without any gastrointestinal discomfort/pain symptoms
Age 40-60 years of both genders
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 might affect the GI function (except gall bladder removal or appendix removal)
History of peptic ulcer disease
Any known bleeding disorder
Allergy to Aspirin
Raised blood pressure
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 (Ibuprofen, Aspirin) in the last 2 months or incidental use in the last 2 weeks prior to screening
Usage of medications, except contraceptives, in the 2 weeks prior to screening
Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome
Participation in other clinical trials in the past 2 months prior to screening
Regular use of probiotics in the last month
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
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