Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
2026年8月4日 更新者：Faming Zhang、The Second Hospital of Nanjing Medical University
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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Faming Zhang, PhD
- 电话号码：086-25-58509883
- 邮箱：fzhang@njmu.edu.cn
学习地点
-
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Jiangsu
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Nanjing、Jiangsu、中国、210011
- 招聘中
- The Second Affiliated Hospital of Nanjing Medical University
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接触：
- Faming Zhang, Professor
- 电话号码：086-25-58509883
- 邮箱：fzhang@njmu.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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
|
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) |
|
实验性的：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.
|
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) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in arterial blood gas
大体时间：Perioperative/Periprocedural
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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
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Perioperative/Periprocedural
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in electrocardiographic data
大体时间：Perioperative/Periprocedural
|
Electrocardiographic data, comprising P-wave morphology, QRS complex duration, QT interval, among other relevant indices, were acquired throughout the periprocedural course.
|
Perioperative/Periprocedural
|
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Changes in electroencephalographic data
大体时间：Perioperative/Periprocedural
|
Electroencephalographic parameters-specifically the wavelengths and amplitudes of alpha, beta, and other relevant frequency bands-were measured throughout the periprocedural course.
|
Perioperative/Periprocedural
|
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Overall patient satisfaction with intervention.
大体时间：Perioperative/Periprocedural
|
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.
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Perioperative/Periprocedural
|
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The incidence rate of adverse events
大体时间：Perioperative/Periprocedural
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The number of adverse reactions reported from the start of treatment to the end of follow-up
|
Perioperative/Periprocedural
|
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The changes in gut microbiota composition and metabolites before and after treatment.
大体时间：Perioperative/Periprocedural
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The 16s-RNA or meta-analysis of gut microbiota will be used.
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Perioperative/Periprocedural
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月2日
初级完成 (估计的)
2031年4月19日
研究完成 (估计的)
2031年5月19日
研究注册日期
首次提交
2026年5月25日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.