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NCT Number: NCT07621367

Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

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.

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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

Subjects who met the inclusion criteria but did not meet any of the exclusion criteria were randomly assigned in a 1:1 ratio to receive 250mL of oxygen (30%-40%) or air through a deep intestinal catheterization four times a day for 5 days. The data of core symptoms (abdominal pain, abdominal distension, defecation), intestinal motility, vital signs and 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

  • 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.

Treatment and study plan

Oxygen 30 %

Other

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

Air

Other

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

Primary outcomes

  1. The changes of core-symptom score in patients with ischemic-hypoxic bowel disease after intervention.

    Time frame: Five-day after intervention

    The severity of core symptoms (including abdominal pain, abdominal distention, and difficult defecation) was assessed using the VAS score, which ranged from 0 to 10 for each symptom, with higher scores indicating more severe symptoms, and the total score ranged from 0 to 30.

Secondary outcomes

  1. Overall patient satisfaction with intervention.

    Time frame: Five-day after intervention

    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.

  2. The incidence rate of adverse events

    Time frame: Five-day after intervention

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

  3. Change in intestinal movement frequency

    Time frame: Baseline and 30 minutes after the last intervention on day 5

    The movement frequency of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement frequency between the two groups will be compared.

  4. Change in intestinal movement amplitude

    Time frame: Baseline and 30 minutes after the last intervention on day 5.

    The movement amplitude of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement amplitude between the two groups will be compared.

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

    Time frame: Five-day after intervention

    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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study

Important dates

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