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.
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- STATUS
- Recruiting
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 Volunteers, *Healthy Patient Studies |
|---|---|
| Clinical Study Identifier | TX225648 |
| Last Modified on | 23 November 2020 |
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