UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015866
Receipt number R000018462
Scientific Title Efficacy of Lactobacillus gasseri on aspirin induced small intestinal injuries - a double-blind, placebo- controlled study
Date of disclosure of the study information 2014/12/06
Last modified on 2016/12/09 16:00:10

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Basic information

Public title

Efficacy of Lactobacillus gasseri on aspirin induced small intestinal injuries - a double-blind, placebo- controlled study

Acronym

Lactobacillus prevents aspirin induced small intestinal injuries

Scientific Title

Efficacy of Lactobacillus gasseri on aspirin induced small intestinal injuries - a double-blind, placebo- controlled study

Scientific Title:Acronym

Lactobacillus prevents aspirin induced small intestinal injuries

Region

Japan


Condition

Condition

aspirin induced small intestinal injuries

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Efficacy of Lactobacillus gasseri(LG) on aspirin induced small intestinal injuries

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

grade, number, and improvement of small intestinal lesions evaluated by capsule endoscopy

Key secondary outcomes

Symptom improvement after taking LG


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Aspirin plus LG

Interventions/Control_2

Aspirin plus placebo

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

regular users of aspirin who have already used more than 4 weeks, and continue to use further over 6 weeks

Key exclusion criteria

1. patients taking misoprostol
2. patients taking other NSAIDs, steroid, anti-platelet agents except aspirin, anti-coagulants, or anti-cancer drugs
3. patients with contraindication to capsule endoscopy
4. patients with active bleeding lesions
5. pregnancy
6. severely ill patients

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Suzuki Takayoshi

Organization

Tokai University School of Medicine

Division name

Division of Gastroenterology & Hepatology

Zip code


Address

143 Shimokasuya Isehara Kanagawa 259-1193 Japan

TEL

0463-93-1121

Email

takayosh@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takayoshi Suzuki

Organization

Tokai University School of Medicine

Division name

Division of Gastroenterology & Hepatology

Zip code


Address

143 Shimokasuya Isehara Kanagawa 259-1193 Japan

TEL

0463-93-1121

Homepage URL


Email

takayosh@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Meiji

Organization

Division

Category of Funding Organization

Profit organization

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

東海大学付属病院/Tokai University School of Medicine


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 06 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

2013 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 13 Day

Last follow-up date


Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 12 Month 06 Day

Last modified on

2016 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018462


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name