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RecruitingNot ApplicableNCT07621367

Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study

Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

90 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

Ischemic Bowel DiseaseHypoxic Events

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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.

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Interventions

OTHEROxygen 30 %

Patients will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days.

OTHERAir

Patients will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.

Locations(1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT07621367