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NCT Number: NCT07621367

Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location status: Recruiting

Location contact

Faming Zhang, Professor

CONTACT

[email protected]

086-25-58509883

About this study

Eligible subjects meeting all inclusion criteria and none of the exclusion criteria will be randomized in a crossover manner within the individual to receive, via a deep intestinal catheter, either 500 mL of oxygen or placebo (sham group), administered at three separate time points over the course of one day. The data of test results before and after treatment were collected to evaluate the efficacy and safety of gut oxygen therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen (O2) -Sham group

Other

Subjects will receive interventions in a crossover manner at three separate time points over one day as follows:

Time 1: 500 mL of oxygen (flow rate: 1 L/min) Time 2: 500 mL of no air (no oxygen) Time 3: 500 mL of oxygen (flow rate: 1 L/min)

Sham -Oxygen (O2) group

Other

Subjects will receive interventions in a crossover manner at three separate time points over one day as follows:

Time 1: 500 mL of no air (no oxygen) Time 2: 500 mL of oxygen (flow rate: 1 L/min) Time 3: 500 mL of oxygen (flow rate: 1 L/min)

Primary outcomes

  1. Changes in arterial blood gas

    Time frame: Perioperative/Periprocedural

    Arterial blood gas analysis results, including partial pressure of oxygen, oxygen concentration, partial pressure of carbon dioxide, oxygenation index, and concentrations of various ions and electrolytes, were obtained at baseline and at intermittent time points within a 30-minute period

Secondary outcomes

  1. Changes in electrocardiographic data

    Time frame: Perioperative/Periprocedural

    Electrocardiographic data, comprising P-wave morphology, QRS complex duration, QT interval, among other relevant indices, were acquired throughout the periprocedural course.

  2. Changes in electroencephalographic data

    Time frame: Perioperative/Periprocedural

    Electroencephalographic parameters-specifically the wavelengths and amplitudes of alpha, beta, and other relevant frequency bands-were measured throughout the periprocedural course.

  3. Overall patient satisfaction with intervention.

    Time frame: Perioperative/Periprocedural

    The patients' satisfaction with the treatment was graded into five levels: very dissatisfied, dissatisfied, average, relatively satisfied, and very satisfied. The differences of treatment satisfaction among different groups were compared.

  4. The incidence rate of adverse events

    Time frame: Perioperative/Periprocedural

    The number of adverse reactions reported from the start of treatment to the end of follow-up

  5. The changes in gut microbiota composition and metabolites before and after treatment.

    Time frame: Perioperative/Periprocedural

    The 16s-RNA or meta-analysis of gut microbiota will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Faming Zhang, PhD

CONTACT

[email protected]

086-25-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Single-center, Double-blind, Randomized, Intra-individual Crossover Controlled Study

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 2, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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