Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease
4. august 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Faming Zhang, PhD
- Telefonnummer: 086-25-58509883
- E-post: fzhang@njmu.edu.cn
Studiesteder
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-
Jiangsu
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Nanjing, Jiangsu, Kina, 210011
- Rekruttering
- The Second Affiliated Hospital of Nanjing Medical University
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Ta kontakt med:
- Faming Zhang, Professor
- Telefonnummer: 086-25-58509883
- E-post: fzhang@njmu.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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) |
|
Eksperimentell: 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) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in arterial blood gas
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in electrocardiographic data
Tidsramme: 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
Tidsramme: 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.
Tidsramme: Perioperative/Periprocedural
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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
Tidsramme: Perioperative/Periprocedural
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The number of adverse reactions reported from the start of treatment to the end of follow-up
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Perioperative/Periprocedural
|
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The changes in gut microbiota composition and metabolites before and after treatment.
Tidsramme: Perioperative/Periprocedural
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The 16s-RNA or meta-analysis of gut microbiota will be used.
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Perioperative/Periprocedural
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
2. august 2026
Primær fullføring (Antatt)
19. april 2031
Studiet fullført (Antatt)
19. mai 2031
Datoer for studieregistrering
Først innsendt
25. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Kardiovaskulære sykdommer
- Hjertesykdommer
- Tegn og symptomer, fordøyelseskanal
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hjertefeil
- Magesmerter
- Uorganiske kjemikalier
- Befolkningskarakteristikker
- Elementer
- Demografi
- Kalkogener
- Gasser
- Oksygen
- Befolkningsgrupper
Andre studie-ID-numre
- GOT-RCT
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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