UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of the healing effect of Lactobacillus casei on low-dose aspirin induced small bowel injury
Title of the study (Brief title)	Clinical trial of the healing effect of Lactobacillus casei on low-dose aspirin induced small bowel injury
Region	Japan

Condition
Condition	Small bowel mucosal injury
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the healing effect of Lactobacillus casei for low-dose aspirin induced small bowel injury by capsule endoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Capsule endoscopic findings (number of red spots, loss of villi and mucosal breaks)
Key secondary outcomes	Change of hemoglobin levels Safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lactobacillus casei
Interventions/Control_2	no treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a. The patients who have taken low-dose aspirin for more than three months and who will take low-dose aspirin for 8 weeks after enrollment. b. Obtaining informed consent
Key exclusion 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.
Target sample size	20

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	0457872640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	Endo Hiroki
Organization	Yokohama City University Graduate School of Medicine
Division name	Gastroenterology Division
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	0457872640
Homepage URL
Email	endo1978@yokohama-cu.ac.jp

Sponsor
Institute	Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2008 Year 12 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 12 Month 03 Day
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 12 Month 03 Day
Last modified on	2016 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001870