Small Bowel Disease Clinical Trial
Official title:
Rifaximin and Misoprostol Combination Therapy for Healing of Small Bowel Ulcers in Aspirin Users With Small Bowel Bleeding: A Double Blind Randomized Trial
Background: Investigators have previously shown that misoprostol can heal small bowel ulcers
in aspirin users with small bowel bleeding. However, the rate of small-bowel mucosal healing
was low with use of misoprostol alone. There is evidence to suggest that bacteria contribute
to the development aspirin-induced ulcers and antibiotics may be useful in its treatment.
Rifaximin, a non-absorbed oral antibiotic that target the gastrointestinal tract have been
shown to be safe and effective in a few other gastrointestinal conditions.
Small bowel capsule is the most sensitive and non-invasive way to investigate the small
bowel. It plays an important role in obscure GIB investigations.
Aims: The aim of this randomized study is to test the hypothesis that misoprostol combined
with rifaximin is superior to misoprostol alone for healing of small bowel ulcers in aspirin
users complicated by small bowel bleeding.
Study design: 8-week double-blind randomized trial
Aspirin is one of the most commonly prescribed drugs worldwide It is widely used as the first
line agent for prevention and treatment of heart diseases and stroke. It is well recognized
that aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) are associated with
risk of upper gastrointestinal (the stomach) bleeding. It is increasingly recognized to have
adverse effects in the small bowel, including ulcers resulting in bleeding.
Bleeding from the small bowel has been very difficult to diagnose as it is beyond the reach
of the conventional endoscopy. But with advances in endoscopic technique, video capsule
endoscopy is now available to visualize the whole of the digestive tract. Capsule endoscopy
is the size and shape of a pill which contains a tiny camera. After ingesting the capsule,
pictures are taken inside of the gastrointestinal tract. Capsule endoscopy is now recommended
to be a noninvasive test to identify source of small bowel bleeding.
Investigators have recently shown that misoprostol can heal small bowel ulcers in aspirin
users with small bowel bleeding. However, the complete healing rate with misoprostol alone
was only 40%. This suggests that we should continue to investigate for additional therapies
in order to achieve higher success rate of healing of aspirin-induced small bowel ulcers.
Rifaximin is a non-absorbed oral antibiotic that targets the gastrointestinal tract. It was
first described in 1982 and introduced into the Italian market 5 years later. Since then,
rifaximin has had U.S. Food and Drug Administration (FDA) approval for treatment of
travellers' diarrhea (year approved = 2004), hepatic encephalopathy (year approved=2010),
irritable bowel syndrome (IBS) with diarrhea (year approved= 2015). Unlike the systematically
available antibiotics, it allows localized enteric targeting of pathogens and is associated
with minimal risk of systemic toxicity or side effects. In addition, the restricted use of
non-absorbed oral antibiotics should also reduce the development of wide spread resistance.
The aim of this study is to test the hypothesis that the combination therapy of rifaximin and
misoprostol is superior to misoprostol alone for healing of small bowel ulcers in aspirin
users complicated by small bowel bleeding.
Participants are invited to this study because some predefined lesions are detected by the
small bowel capsule endoscopy. Participants will be randomly assigned to receive either a
combination therapy of misoprostol and rifaximin or misoprostol and rifaximin placebo for 8
weeks. Participants will be contacted by telephone after 1 week for any adverse events.
Participants will then return at Week 8 to undergo a follow-up capsule endoscopy. Lab tests,
drug compliance, and adverse events will be assessed.
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