Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

NCT07621367 | Recruiting DMC

• 1 other identifier: GOT-RCT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Bowel Disease; Hypoxic Events

Keywords

ischemic bowel disease; heart failure; abdominal pain; abdominal distension; difficult defecation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall patient satisfaction with intervention.

  Five-day after intervention

• The incidence rate of adverse events

  Five-day after intervention

• Change in intestinal movement frequency

  Baseline and 30 minutes after the last intervention on day 5

• Change in intestinal movement amplitude

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

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

  Five-day after intervention

Study Arms (2)

Treatment

EXPERIMENTAL

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

Other: Oxygen 30 %

Control

PLACEBO COMPARATOR

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

Other: Air

Interventions

Oxygen 30 % OTHER

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

Treatment

Air OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 40008452 BACKGROUND

• 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.

  PMID: 28853446 BACKGROUND

• 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.

  PMID: 36768744 BACKGROUND

• 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.

  PMID: 38113056 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Abdominal Pain

Interventions

Air

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 2, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): April 19, 2031
• Study Completion (Estimated): May 19, 2031
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)