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The Protective Role of Preoperative Stimulation of GABA Before Ileostomy Closure

9. november 2026 opdateret af: Wei Guo, Qilu Hospital of Shandong University

The goal of this clinical trial is to explore whether preoperative gamma aminobutyric acid (GABA) lavage of the diverted colon improved postoperative bowel recovery, with time to first flatus as the primary outcome. Participants will be divided into two groups. One group included patients treated with stimulation of GABA prior to ileostomy reversal surgery; the other control group was stimulated with 0.9% saline. Researchers will compare incidence of complications such as postoperative ileus, diarrhea and other parameters such as time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay, multi-omic profiling of the gut microbiome and metabolome and serum biochemical measurements evaluating potential systemic effects, etc.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Shandong
      • Jinan, Shandong, Kina, 250012
        • Qilu Hospital of Shandong University

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • over 18 years of age;
  • body mass index (BMI) 18.5-28 kg/m2;
  • having protective ileostomy after colorectal carcinoma surgery free of disease;
  • with endoscopic and histological confirmation of diversion colitis;
  • no oral antibiotics or probiotic within 3 months;
  • having signed the informed consent.

Exclusion Criteria:

  • under 18 years of age;
  • a history of drug or alcohol abuse;
  • clinical history and histological confirmation of inflammatory bowel disease or other gastrointestinal motility disorders with colorectal involvement;
  • previous abdominal surgery;
  • mental disorders;
  • other serious chronic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, etc;
  • serious perioperative complications such as anastomotic rupture after surgery;
  • oral antibiotics or probiotic within three months;
  • participation in any other studies within the past 3 months;
  • refusal to participate in the study.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: preoperative stimulation of diverted colorectal segments with GABA before ileostomy closure surgery

Patients allocated to the GABA group received local preoperative enema stimulation of the diverted distal colorectal segment once daily for four consecutive days before ileostomy closure. For each session, the contents of four GNC GABA 750-mg capsules, providing 3,000 mg of labeled GABA, were dissolved in 100 mL of sterile 0.9% sodium chloride injection manufactured by Shijiazhuang No. 4 Pharmaceutical Co., Ltd. (Shijiazhuang, China), yielding a final nominal GABA concentration of 30 mg/mL. GABA was supplied as commercially available dietary-supplement-grade capsules (GNC Holdings, LLC, Pittsburgh, PA, USA). According to the manufacturer's label, each capsule contained 750 mg of gamma-aminobutyric acid; a numerical analytical purity specification was not provided by the manufacturer. The preparation was made aseptically immediately before administration and infused slowly over 10-20 minutes through a sterile 14-Ch Foley catheter connected to an infusion set.
Kosttilskud: preoperative stimulation of the diverted distal colorectal segment with GABA before ileostomy closure surgery

Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline.
Sham-komparator: control group was stimulated with 0.9% saline

Patients allocated to the sham group received 100 mL sterile 0.9% sodium chloride injection following an identical protocol, including catheter insertion, infusion route, infusion volume, infusion duration, and symptom recording, but without GABA administration. After completion of four enema sessions, all patients underwent ileostomy closure within the subsequent 24 h.
Kosttilskud: preoperative stimulation of the efferent loop with only physiological saline

Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of 100 ml of 0.9% physiological saline.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
time to first flatus
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

time from the end of surgery to the first passage of flatus
From date of the end of surgery until the date of discharge, assessed up to 20 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the incidence of POI (Postoperative Ileus)
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

the incidence of POI
From date of the end of surgery until the date of discharge, assessed up to 20 days
time to first passage of stool
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

time to first passage of stool
From date of the end of surgery until the date of discharge, assessed up to 20 days
incidence of watery stool
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

incidence of watery stool
From date of the end of surgery until the date of discharge, assessed up to 20 days
time to first liquid intake
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

time to first liquid intake
From date of the end of surgery until the date of discharge, assessed up to 20 days
time to tolerance of a solid diet
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

time to tolerance of a solid diet
From date of the end of surgery until the date of discharge, assessed up to 20 days
total and postoperative lengths of hospital stay
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

total and postoperative lengths of hospital stay
From date of the end of surgery until the date of discharge, assessed up to 20 days
profiling of the gut microbiome
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

metagenomic sequencing of the gut microbiota.
From date of the end of surgery until the date of discharge, assessed up to 20 days
profiling of metabolome
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

metabolomic profiling of colonic lavage fluid and plasma.
From date of the end of surgery until the date of discharge, assessed up to 20 days
serum biochemical measurements
Tidsramme: From date of the end of surgery until the date of discharge, assessed up to 20 days

biochemical indicators of hepatic and renal function, lipid metabolism, and glucose metabolism
From date of the end of surgery until the date of discharge, assessed up to 20 days

Samarbejdspartnere og efterforskere

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

Sponsor

Qilu Hospital of Shandong 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 (Faktiske)

20. juni 2023

Primær færdiggørelse (Faktiske)

30. april 2024

Studieafslutning (Faktiske)

15. august 2024

Datoer for studieregistrering

Først indsendt

30. maj 2023

Først indsendt, der opfyldte QC-kriterier

7. juni 2023

Først opslået (Faktiske)

15. juni 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • KYLL-202212-066-1

Plan for individuelle deltagerdata (IPD)

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