Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease (NCT07621367) | Clinical Trial Compass
RecruitingNot Applicable
Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
China100 participantsStarted 2026-08-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Oxygenation index \>400 without supplemental oxygen and/or resting oxygen saturation ≥96%;
* Primary organic gastrointestinal diseases, intestinal obstruction, inflammatory bowel disease, or severe hepatic/renal failure;
* Hemodynamically unstable, unable to tolerate sequential intervention (time-sequenced intervention);
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as Phase NA and is measuring changes in arterial blood gas — what does that tell us about how early this research is, and does that mean we don't yet know much about whether gut oxygen therapy is safe or effective for my condition?
2Since the trial is focused on chronic ischemic-hypoxic enteropathy, how confident is my care team that this is actually what I have, and does my specific diagnosis make this trial worth discussing as an option?
3Gut oxygen therapy sounds like it delivers oxygen directly to the intestines — can you explain how that works in practice, what the treatment would involve day-to-day, and whether the demands of participating would be realistic for my situation?
4Are there any established or standard treatments for chronic ischemic-hypoxic bowel disease that I should try first before considering an experimental approach like this one?
5Because the primary outcome being measured is changes in arterial blood gas rather than symptom relief or long-term outcomes, what would that mean for me as a participant — would I be contributing to early research without necessarily seeing a direct personal benefit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in arterial blood gas
Timeframe: Perioperative/Periprocedural
Trial details
NCT IDNCT07621367
SponsorThe Second Hospital of Nanjing Medical University