UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001550
Receipt No. R000001870
Scientific Title Clinical trial of the healing effect of Lactobacillus casei on low-dose aspirin induced small bowel injury
Date of disclosure of the study information 2008/12/04
Last modified on 2016/06/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical trial of the healing effect of Lactobacillus casei on low-dose aspirin induced small bowel injury
Acronym Clinical trial of the healing effect of Lactobacillus casei on low-dose aspirin induced small bowel injury
Scientific Title Clinical trial of the healing effect of Lactobacillus casei on low-dose aspirin induced small bowel injury
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 0457872640
Email nakajima-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Endo Hiroki
Organization Yokohama City University Graduate School of Medicine
Division name Gastroenterology Division
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 12 Month 03 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000001870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.