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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxic Events; Ischemic Bowel Disease
• Intervention / Treatment: Other: Oxygen 30 %; Other: Air

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faming Zhang, PhD; Phone Number: 086-25-58509883; Email: fzhang@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Faming Zhang, Professor; Phone Number: 086-25-58509883; Email: fzhang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days	Other: Oxygen 30 %; Patients will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days.
Placebo Comparator: Control; Participants will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.	Other: Air; Patients will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of core-symptom score in patients with ischemic-hypoxic bowel disease 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.	Five-day after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient satisfaction with 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.	Five-day after intervention
The incidence rate of adverse events	The number of adverse reactions reported by subjects from the start of treatment to the end of follow-up	Five-day after intervention
Change in intestinal movement frequency	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.	Baseline and 30 minutes after the last intervention on day 5
Change in intestinal movement amplitude	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.	Baseline and 30 minutes after the last intervention on day 5.
The changes in gut microbiota composition and metabolites before and after treatment.	The 16s-RNA or meta-analysis of gut microbiota will be used.	Five-day after intervention

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• Chen A, Teng C, Wei J, Wu X, Zhang H, Chen P, Cai D, Qian H, Zhu H, Zheng X, Chen X. Gut microbial dysbiosis exacerbates long-term cognitive impairments by promoting intestinal dysfunction and neuroinflammation following neonatal hypoxia-ischemia. Gut Microbes. 2025 Dec;17(1):2471015. doi: 10.1080/19490976.2025.2471015. Epub 2025 Feb 26.
• Van Welden S, Selfridge AC, Hindryckx P. Intestinal hypoxia and hypoxia-induced signalling as therapeutic targets for IBD. Nat Rev Gastroenterol Hepatol. 2017 Oct;14(10):596-611. doi: 10.1038/nrgastro.2017.101. Epub 2017 Aug 30.
• Dvornikova KA, Platonova ON, Bystrova EY. Hypoxia and Intestinal Inflammation: Common Molecular Mechanisms and Signaling Pathways. Int J Mol Sci. 2023 Jan 26;24(3):2425. doi: 10.3390/ijms24032425.
• Song S, Li R, Wu C, Dong J, Wang P. EFFECTS OF HYPERBARIC OXYGEN THERAPY ON INTESTINAL ISCHEMIA-REPERFUSION AND ITS MECHANISM. Shock. 2024 May 1;61(5):650-659. doi: 10.1097/SHK.0000000000002287. Epub 2023 Dec 13.

Study record dates

Study Major Dates

• Study Start (Estimated): May 28, 2026
• Primary Completion (Estimated): April 19, 2031
• Study Completion (Estimated): May 19, 2031

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: heart failure; abdominal pain; abdominal distension; difficult defecation; ischemic bowel disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cardiovascular Diseases; Heart Diseases; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Failure; Abdominal Pain; Environment and Public Health; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Atmosphere; Meteorological Concepts; Air
• Other Study ID Numbers: GOT-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No