Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Ischemic-Hypoxic Enteropathy
• Intervention / Treatment: Other: Oxygen (O2) -Sham group; Other: Sham -Oxygen (O2) group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• 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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crossover Sequence A - O2 then Sham; Eligible subjects meeting all inclusion criteria and none of the exclusion criteria randomized to this sequence will receive interventions at three separate time points over one day via a deep intestinal catheter	Other: Oxygen (O2) -Sham group; 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)
Experimental: Crossover Sequence B - Sham then Oxygen (O2); Eligible subjects meeting all inclusion criteria and none of the exclusion criteria randomized to this sequence will receive reverse interventions at three separate time points over one day via a deep intestinal catheter.	Other: Sham -Oxygen (O2) group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in arterial blood gas	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	Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in electrocardiographic data	Electrocardiographic data, comprising P-wave morphology, QRS complex duration, QT interval, among other relevant indices, were acquired throughout the periprocedural course.	Perioperative/Periprocedural
Changes in electroencephalographic data	Electroencephalographic parameters-specifically the wavelengths and amplitudes of alpha, beta, and other relevant frequency bands-were measured throughout the periprocedural course.	Perioperative/Periprocedural
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.	Perioperative/Periprocedural
The incidence rate of adverse events	The number of adverse reactions reported from the start of treatment to the end of follow-up	Perioperative/Periprocedural
The changes in gut microbiota composition and metabolites before and after treatment.	The 16s-RNA or meta-analysis of gut microbiota will be used.	Perioperative/Periprocedural

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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 2, 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): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 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; Inorganic Chemicals; Population Characteristics; Elements; Demography; Chalcogens; Gases; Oxygen; Population Groups
• 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