Clinical trial of the healing effect of Lactobacillus casei on low-dose aspirin induced small bowel injury

UMIN ID: UMIN000001550

Registered date:04/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Small bowel mucosal injury
• Date of first enrollment: 2008/12/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Lactobacillus casei
no treatment

Outcome(s)

• Primary Outcome: Capsule endoscopic findings (number of red spots, loss of villi and mucosal breaks)
• Secondary Outcome: Change of hemoglobin levels Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: a. The patients with dysphagia. b. Pregnant or lactating women. c. The patients who have history of the ileus or stricture or fistula of the intestine. d. The patients who have Crohn's disease, Behchet's disease. e. The patient with pacemaker or other medical electronic equipment. f. Allergic or idiosyncratic to the drug. g. Useage of misoprostol. h. Useage of NSAIDs or anti-cancer drugs. i. Chronic alcohol consumption. j. A history of abdominal surgery. k. severely ill patients. l. The subject of any other clinical test/trial which will affect the results this study. m. Can not comply with the study requirements or cannot follow instructions for the device. n. Do not agree to remove the capsule either by endoscopically or surgically when retention occurred. o. Inadequate to entry judged by investigators.

Related Information

• Primary Sponsor: Gastroenterology Division, Yokohama City University Graduate School of Medicine
• Source(s) of Monetary Support: Yokohama City University Graduate School of Medicine