Chronic Ischemic-Hypoxic EnteropathyNCT07621367

Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

A study of Chronic Ischemic-Hypoxic Enteropathy, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Ischemic-Hypoxic Enteropathy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteChina
Study dates: 2 Aug 2026to 19 May 2031
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Faming Zhang, PhD contact

086-25-58509883

fzhang@njmu.edu.cn

China1 site, 1 recruiting

The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, Professor, 086-25-58509883, fzhang@njmu.edu.cn
Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Chronic Ischemic-Hypoxic Enteropathy
Being tested: Oxygen (O2) -Sham group, Sham -Oxygen (O2) group
Keywords: ischemic bowel disease, heart failure, abdominal pain, abdominal distension, difficult defecation
Medical subject headings: Heart Failure, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxygen (O2) -Sham groupOther
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) groupOther
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)

Study groups in NCT07621367
Study group	Role	What they receive
Crossover Sequence A - O2 then Sham	Experimental	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 Receives: Other: Oxygen (O2) -Sham group
Crossover Sequence B - Sham then Oxygen (O2)	Experimental	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. Receives: Other: Sham -Oxygen (O2) group

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Perioperative/Periprocedural

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Perioperative/Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202619 May 2031

First posted2 Jun 2026
Study start2 Aug 2026 (estimated)
Primary completion19 Apr 2031 (estimated)
Study completion19 May 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Ischemic-Hypoxic EnteropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07621367
Sponsor's protocol ID: GOT-RCT
Status last verified: Aug 2026
First submitted: 25 May 2026
Last updated: 5 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 40008452
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.
PubMed 28853446
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.
PubMed 36768744

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Single-center, Double-blind, Randomized, Intra-individual Crossover Controlled Study
ClinicalTrials.gov ID: NCT07621367
Acronym / sponsor ID: GOT-RCT
Conditions: Chronic Ischemic-Hypoxic Enteropathy
Keywords: ischemic bowel disease, heart failure, abdominal pain, abdominal distension, difficult defecation
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
Study start: 2 Aug 2026 (estimated)
Primary completion: 19 Apr 2031 (estimated)
Study completion: 19 May 2031 (estimated)
First posted: 2 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Crossover Sequence A - O2 then Sham	Experimental	Other: Oxygen (O2) -Sham groupEligible 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
Crossover Sequence B - Sham then Oxygen (O2)	Experimental	Other: Sham -Oxygen (O2) groupEligible 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxygen (O2) -Sham groupSubjects 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)	Other	Crossover Sequence A - O2 then Sham
Sham -Oxygen (O2) groupSubjects 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)	Other	Crossover Sequence B - Sham then Oxygen (O2)

Primary outcome

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

5 secondary outcomes

Changes in electrocardiographic data
Time frame: Perioperative/Periprocedural
Changes in electroencephalographic data
Time frame: Perioperative/Periprocedural
Overall patient satisfaction with intervention.
Time frame: Perioperative/Periprocedural
The incidence rate of adverse events
Time frame: Perioperative/Periprocedural
The changes in gut microbiota composition and metabolites before and after treatment.
Time frame: Perioperative/Periprocedural

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Background: PubMed 40008452Chen 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.
Background: PubMed 28853446Van 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.
Background: PubMed 36768744Dvornikova 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Faming Zhang, PhD contact

086-25-58509883

fzhang@njmu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Chronic Ischemic-Hypoxic Enteropathy, run by The Second Hospital of Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faming Zhang, PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in arterial blood gas (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07621367, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.