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Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease

1. juni 2026 opdateret af: Faming Zhang, The Second Hospital of Nanjing Medical University

Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210011
        • Rekruttering
        • The Second Affiliated Hospital of Nanjing Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of intestinal ischemia and hypoxia-related diseases caused by conditions such as ischemic bowel disease, heart failure, etc., presenting with recurrent or persistent abdominal pain and/or distension, and difficulty in defecation. Examples include: heart failure-related defecation difficulty, severe malnutrition combined with defecation difficulty, acute ischemic bowel disease, and chronic ischemic bowel disease.
  • At least able to perform bedside activities and able to defecate in conventional positions (sitting or squatting).
  • Age ≥18 years, and able to voluntarily sign informed consent.

Exclusion Criteria:

  • Acute intestinal emergencies such as acute intestinal obstruction, intestinal perforation, or active massive gastrointestinal bleeding.
  • Intestinal fistula.
  • History of abdominal surgery within the recent past (<1 month).
  • Severe uncontrolled arrhythmia or respiratory failure.
  • Cardiac function Class IV (NYHA Class IV).
  • Patients with abnormal visceral pressure sensitivity.
  • Inability to cooperate with study assessments.
  • Other conditions that, in the opinion of the investigator, make the subject unsuitable for inclusion.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment
Participants will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days
Andet: Oxygen 30 %
Patients will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days.
Placebo komparator: Control
Participants will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.
Andet: Air
Patients will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The changes of core-symptom score in patients with ischemic-hypoxic bowel disease after intervention.
Tidsramme: Five-day 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall patient satisfaction with intervention.
Tidsramme: Five-day after 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
The incidence rate of adverse events
Tidsramme: Five-day after intervention
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
Tidsramme: Baseline and 30 minutes after the last intervention on day 5
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
Tidsramme: Baseline and 30 minutes after the last intervention on day 5.
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.
Tidsramme: Five-day after intervention
The 16s-RNA or meta-analysis of gut microbiota will be used.
Five-day after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Second Hospital of Nanjing Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

28. maj 2026

Primær færdiggørelse (Anslået)

19. april 2031

Studieafslutning (Anslået)

19. maj 2031

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GOT-RCT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hypoxiske hændelser

Kliniske forsøg med Oxygen 30 %

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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