Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
4 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Faming Zhang, PhD
- Telefonnummer: 086-25-58509883
- E-post: fzhang@njmu.edu.cn
Studieorter
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210011
- Rekrytering
- The Second Affiliated Hospital of Nanjing Medical University
-
Kontakt:
- Faming Zhang, Professor
- Telefonnummer: 086-25-58509883
- E-post: fzhang@njmu.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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) |
|
Experimentell: 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) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in arterial blood gas
Tidsram: 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
|
Perioperative/Periprocedural
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in electrocardiographic data
Tidsram: 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
|
|
Changes in electroencephalographic data
Tidsram: 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
|
|
Overall patient satisfaction with intervention.
Tidsram: 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.
|
Perioperative/Periprocedural
|
|
The incidence rate of adverse events
Tidsram: Perioperative/Periprocedural
|
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.
Tidsram: Perioperative/Periprocedural
|
The 16s-RNA or meta-analysis of gut microbiota will be used.
|
Perioperative/Periprocedural
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
2 augusti 2026
Primärt slutförande (Beräknad)
19 april 2031
Avslutad studie (Beräknad)
19 maj 2031
Studieregistreringsdatum
Först inskickad
25 maj 2026
Först inskickad som uppfyllde QC-kriterierna
1 juni 2026
Första postat (Faktisk)
2 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GOT-RCT
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .