Oxygen Delivered Into the Gut for Poor Blood and Oxygen Supply to the Bowel
Tests oxygen given into the intestine in adults with chronic ischemic-hypoxic enteropathy.
Plain-language title generated from the registry record
Registry title: Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
Key facts
- Where
- Nanjing, ChinaSee the site
Where in China
- The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Second Hospital of Nanjing Medical University
- Trial code
- NCT07621367
- Record updated
- 5 August 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Single-center, Double-blind, Randomized, Intra-individual Crossover Controlled Study
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.
Inclusion: Definite diagnosis of chronic heart failure or obstructive sleep apnea (OSA) with chronic hypoxia; Comorbid intestinal dysmotility (abdominal distension, constipation, diarrhea, or abdominal pain); Disease duration ≥1 month with poor response to conventional treatment; Tolerability of transendoscopic enteral tubing (TET) with successful placement of the tube at the ileocecal junction; Age 18-80 years; Able to cooperate with bed rest therapy and provide written informed consent.
Exclusion: Primary organic gastrointestinal diseases, intestinal obstruction, inflammatory bowel disease, or severe hepatic/renal failure; Presence of cough or spinal disorders that prevent maintaining a resting state during bed rest; Failure of arterial catheterization or endoscopic tube placement; Mental or cognitive impairment that precludes cooperation with assessments; Oxygenation index >400 without supplemental oxygen and/or resting oxygen saturation ≥96%; Hemodynamically unstable, unable to tolerate sequential intervention (time-sequenced intervention).