Clinical Trial

Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

Recruiting
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Summary
This single-center, double-blind, randomized, intra-individual crossover controlled study aims to investigate the efficacy and safety of intestinal oxygen therapy via a deep intestinal catheter as a targeted route for intestinal oxygen delivery in the treatment of ischemic-hypoxic enteropathy, and simultaneously to explore and verify the chronobiological differences. Data have been obtained from the study based on the first version of our pilot study. Considering ethics and cost-effectiveness, a new protocol needs to be designed to achieve the research goals with minimal intervention, minimal cost, and the smallest sample size.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-08-06
notable Enrollment increased: 90 -> 100 participants 2026-08-06
Trial Details
NCT Number NCT07621367
Lead Sponsor The Second Hospital of Nanjing Medical University
Conditions Chronic Ischemic-Hypoxic Enteropathy
Enrollment 100 participants
Start Date 2026-08-02
Primary Completion 2031-04-19 (estimated)
Study Completion 2031-05-19 (estimated)
Updated on ClinicalTrials.gov 2026-08-05