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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days |
|
| Control | Placebo Comparator | Participants will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen 30 % | Other | Patients will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faming Zhang, PhD | Contact | 086-25-58509883 | fzhang@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40008452 | Background | 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. | |
| 28853446 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| Air | Other | Patients will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days. |
|
| 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 |
| 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. |
| 36768744 | 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. |
| 38113056 | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |