UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study on the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in patients taking NSAIDs for long periods
Acronym	A prospective multicenter observational study on the correlation between oxidative stress/antioxidant status and NSAIDs-induced small intestinal mucosal injury
Scientific Title	A clinical study on the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in patients taking NSAIDs for long periods
Scientific Title:Acronym	A prospective multicenter observational study on the correlation between oxidative stress/antioxidant status and NSAIDs-induced small intestinal mucosal injury
Region	Japan

Condition
Condition	Subjects who take NSAIDs(including low-dose aspirin) for more than 3 months and are suspected of occult OGIB
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to evaluate the incidence of NSAID-induced small intestinal mucosal injury, we will screen patients taking NSAIDs for long periods by using a capsule endoscopy. We will also ascertain the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in each case, and research the antioxidant treatment in the future.
Basic objectives2	Others
Basic objectives -Others	clinical verification
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlation between the number of oxidative stress marker/antioxidant status/regulatory T-cells in serum and the incidence of small intestinal mucosal injury
Key secondary outcomes	1) The incidence rate of NSAIDs-induced small intestinal mucosal injury in a capsule endoscopy 2) The correlation between the rate of PPI or H2-RA takers and the extent of small intestinal mucosal injury

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	1) Subjects obtained written informed consent 2) Subjects taking NSAIDs(including commercial drugs and low-dose aspirin) for more than 3 months 3) Subjects who have iron deficient anemia the cause of which is unclear with esophagogastroduodenoscopy and colonoscopy, and are diagnosed Occult OGIB
Key exclusion criteria	1) Pregnant and nursing women 2) Subjects with contraindication of capsule endoscopy(gastrointestinal obstruction, stenosis, or fistula and a disorder of swallowing, etc) 3) Subjects who are judged inappropriate for the participation of the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Okada
Organization	Okayama University Hospital
Division name	Department of Endoscopy
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL	086-235-7219
Email	hiro@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshiyasu Kono
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL	086-235-7219
Homepage URL
Email	hxnwq178@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology, Okayama University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Iwakuni Medical Center Okayama Saiseikai General Hospital Okayama Citizen's Hospital Japanese Red Cross Okayama Hospital Kagawa Prefectual Central Hospital Kurashiki Central Hospital Tsuyama Central Hospital Japanese Red Cross Society Himeji Hospital Fukuyama Medical Center Fukuyama City Hospital
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	2013 Year 09 Month 17 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 23 Day
Date of IRB	2013 Year 07 Month 23 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will asess the oxidative stress/antioxidant status by measuring d-ROM/OXY in the serum of the patients who are suspected of NSAIDs-induced small intestinal mucosal injury. After that we will perform a capsule endoscopy and score the extent of mucosal injury.

Management information
Registered date	2013 Year 09 Month 15 Day
Last modified on	2020 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013733