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A clinical study on the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in patients taking NSAIDs for long periods

A clinical study on the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in patients taking NSAIDs for long periods - A prospective multicenter observational study on the correlation between oxidative stress/antioxidant status and NSAIDs-induced small intestinal mucosal injury

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000011775
Enrollment
100
Registered
2013-09-17
Start date
2013-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects who take NSAIDs(including low-dose aspirin) for more than 3 months and are suspected of occult OGIB

Interventions

None listed

Sponsors

Department of Gastroenterology, Okayama University Hospital
Lead Sponsor
Iwakuni Medical Center Okayama Saiseikai General Hospital Okayama Citizen&#39
Collaborator
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
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The correlation between the number of oxidative stress marker/antioxidant status/regulatory T-cells in serum and the incidence of small intestinal mucosal injury

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYoshiyasu Kono

Okayama University Hospital Department of Gastroenterology

hxnwq178@yahoo.co.jp086-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026