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Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

RECRUITINGN/ASponsored by The Second Hospital of Nanjing Medical University
Actively Recruiting
PhaseN/A
SponsorThe Second Hospital of Nanjing Medical University
Started2026-05-28
Est. completion2031-04-19
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

This multicenter, randomized, double-blind, placebo-controlled clinical trial aimed to investigate the efficacy and safety of gut oxygen therapy in the treatment of ischemic-hypoxic bowel disease using deep intestinal catheterization as a targeted route for gut oxygen delivery.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Clinical diagnosis of intestinal ischemia and hypoxia-related diseases caused by conditions such as ischemic bowel disease, heart failure, etc., presenting with recurrent or persistent abdominal pain and/or distension, and difficulty in defecation. Examples include: heart failure-related defecation difficulty, severe malnutrition combined with defecation difficulty, acute ischemic bowel disease, and chronic ischemic bowel disease.
* At least able to perform bedside activities and able to defecate in conventional positions (sitting or squatting).
* Age ≥18 years, and able to voluntarily sign informed consent.

Exclusion Criteria:

* Acute intestinal emergencies such as acute intestinal obstruction, intestinal perforation, or active massive gastrointestinal bleeding.
* Intestinal fistula.
* History of abdominal surgery within the recent past (\<1 month).
* Severe uncontrolled arrhythmia or respiratory failure.
* Cardiac function Class IV (NYHA Class IV).
* Patients with abnormal visceral pressure sensitivity.
* Inability to cooperate with study assessments.
* Other conditions that, in the opinion of the investigator, make the subject unsuitable for inclusion.

Conditions3

Heart DiseaseHypoxic EventsIschemic Bowel Disease

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