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Effect of endogenous mucosal protective agents on intestinal mucosal injury induced by low dose aspirin

Effect of endogenous mucosal protective agents on intestinal mucosal injury induced by low dose aspirin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084094
Enrollment
Unknown
Registered
2024-05-10
Start date
2024-05-15
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Intestinal mucosal injury

Interventions

Experimental group:aspirin+teprenone
Experimental group:aspirin+glutamine

Sponsors

Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients aged 18-80 years; (2) Agree to comply with all research procedures; (3) Provide written informed consent; (4) Capsule endoscopy was successfully completed (the entire upper digestive tract and small intestine were visible) without ulceration or active bleeding (erosion allowed); (5) Have not used anticoagulants or non-steroidal anti-inflammatory drugs before, use low-dose aspirin 100 mg/ time, once a day for the first time; Aspirin of the same regimen was continued during the observation period of this study.

Exclusion criteria

Exclusion criteria: (1) Use non-steroidal anti-inflammatory drugs or anticoagulants other than aspirin; (2) Subjects using other mucosal protective agents, acid suppressors, antibiotics, thyroxine sodium and other drugs; (3) have active gastrointestinal bleeding or ulcers, or have had gastrointestinal bleeding or ulcers within the past 24 months; Have a history of gastrointestinal or abdominal surgery, except for simple procedures such as polypectomy, cholecystectomy or appendectomy that do not change the gastrointestinal anatomy; (4) Contraindications for capsule endoscopy, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticulum, etc.; Symptoms of gastrointestinal obstruction, such as pain or difficulty swallowing; Poor surgical conditions or refusal to perform abdominal surgery when needed (i.e. if the capsule does not pass and cannot be removed by endoscope); (5) severe liver and kidney dysfunction, cardiopulmonary dysfunction; (6) Subjects who became pregnant or wished to become pregnant during the study period; (7) Subjects whose cecum could not be reached by capsule endoscopy; (8) Hemoglobin < 100g/L, platelet count <100 × 10^9/L; (9) any conditions that may interfere with any study procedure, such as dementia, mobility problems, alcohol consumption, etc.; (10) any comorbidities with an estimated survival time <12 months (e.g. progressive cancer, chronic obstructive pulmonary disease, etc.); (11) Participation in any other investigational drug or device that does not meet its primary endpoint.

Design outcomes

Primary

MeasureTime frame
The number of small intestinal mucosal lesions;intestinal flora;

Secondary

MeasureTime frame
hemoglobin;Fecal occult blood test;

Countries

China

Contacts

Public ContactMei Liu

Tongji Medical College, Huazhong University of Science and Technology; Department of Gastroenterology,Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

fliumei@126.com+86 186 2771 4881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026