Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease (Aimed at chronic ischemic-enteropathy)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, intra-individual crossover study conducted at a single center to test gut oxygen therapy through a deep intestinal catheter. Participants with chronic ischemic-hypoxic enteropathy and comorbid hypoxic conditions will receive both oxygen and placebo in a crossover design across three time points in one day. Outcomes will compare efficacy and safety of therapy versus sham, while also exploring circadian timing effects. The protocol emphasizes ethics, cost-effectiveness, and minimal intervention with a small sample size and iterative data collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Faming Zhang, PhD
• Email: fzhang@njmu.edu.cn
• Phone: 086-25-58509883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.