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Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

NCT07621367 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-05

No results posted yet for this study

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.

Conditions

  • Chronic Ischemic-Hypoxic Enteropathy

Interventions

OTHER

Oxygen (O2) -Sham group

Subjects will receive interventions in a crossover manner at three separate time points over one day as follows: Time 1: 500 mL of oxygen (flow rate: 1 L/min) Time 2: 500 mL of no air (no oxygen) Time 3: 500 mL of oxygen (flow rate: 1 L/min)

OTHER

Sham -Oxygen (O2) group

Subjects will receive interventions in a crossover manner at three separate time points over one day as follows: Time 1: 500 mL of no air (no oxygen) Time 2: 500 mL of oxygen (flow rate: 1 L/min) Time 3: 500 mL of oxygen (flow rate: 1 L/min)

Sponsors & Collaborators

  • The Second Hospital of Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-02
Primary Completion
2031-04-19
Completion
2031-05-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621367 on ClinicalTrials.gov