NCT07621367Recruiting
Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Single-center, Double-blind, Randomized, Intra-individual Crossover Controlled Study
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 May 2026
- Start date
- 2 Aug 2026
- Primary completion date
- 19 Apr 2031
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Diseases
- Heart failure
- NCT number
- NCT07621367
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 2 Aug 2026 to the primary completion date, 19 Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Oxygenation index \>400 without supplemental oxygen and/or resting oxygen saturation ≥96%;
- Hemodynamically unstable, unable to tolerate sequential intervention (time-sequenced intervention);
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.