- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07704255
Study on the Effect of Fecal Microbiota Transplantation on Eradication of Refractory Helicobacter Pylori Infection
10. juli 2026 opdateret af: Gao Caiping, Sichuan Provincial People's Hospital
To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
10
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Gao Caiping, Doctor
- Telefonnummer: 17708130286
- E-mail: gaocaip@126.com
Undersøgelse Kontakt Backup
- Navn: Xia Yuehan, Master
- Telefonnummer: 13438917607
- E-mail: 694159760@qq.com
Studiesteder
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 601172
- Rekruttering
- Sichuan Provincial People's Hospital
-
Kontakt:
- Caiping Gao, Doctor
- Telefonnummer: 17708130286
- E-mail: gaocaip@126.com
-
-
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:
- 1. Ages 18-70
- 2. Hp infection treatment failed ≥4 times with guidelines-recommended therapies
- 3. Patients with early gastric cancer, peptic ulcer, gastric MALT lymphoma, atrophic gastritis and other diseases requiring the eradication of Hp.
Exclusion Criteria:
- 1. Antibiotics and bismuth were taken within 4 weeks before this treatment; Or had taken PPI, H2 receptor antagonist, P-CAB within 2 weeks prior to treatment;
- 2. Pregnant or lactating women;
- 3. Those who are allergic to the investigational drugs used in this test or have contraindications;
- 4. Participated in other drug trials within 3 months before the treatment of this trial;
- 5. There are other serious diseases that affect the evaluation of this study at the same time, or they cannot correctly express their own complaints and cannot cooperate;
- 6. Subjects with dysphagia;
- 7. Patients with malignant tumors, serious concomitant diseases, severe ulcer bleeding or perforation;
- 8. Patients judged by the investigator to be unsuitable for clinical trials.
- 9. Those who do not want to sign the informed consent for 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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: washed microbiota
Study on the effect of washed microbiota transplantation on eradication of refractory Helicobacter pylori infection.
|
Received transanal fecal bacteria transplant
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Whether Hp is successfully eradicated
Tidsramme: 2years
|
The successful eradication of Hp was determined by 13C urea breath test, immunohistochemical staining of Hp and Hp culture.test,
immunohistochemical staining of gastric mucosa and Hp culture
|
2years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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
- Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.
- Guarner F, Malagelada JR. Gut flora in health and disease. Lancet. 2003 Feb 8;361(9356):512-9. doi: 10.1016/S0140-6736(03)12489-0.
- Chen YC, Malfertheiner P, Yu HT, Kuo CL, Chang YY, Meng FT, Wu YX, Hsiao JL, Chen MJ, Lin KP, Wu CY, Lin JT, O'Morain C, Megraud F, Lee WC, El-Omar EM, Wu MS, Liou JM. Global Prevalence of Helicobacter pylori Infection and Incidence of Gastric Cancer Between 1980 and 2022. Gastroenterology. 2024 Apr;166(4):605-619. doi: 10.1053/j.gastro.2023.12.022. Epub 2024 Jan 2.
- Kuo CJ, Lee CH, Chang ML, Lin CY, Lin WR, Su MY, Chiu CH, Tseng CN, Wu YS, Chiu CT, Lai CH. Multidrug resistance: The clinical dilemma of refractory Helicobacter pylori infection. J Microbiol Immunol Infect. 2021 Dec;54(6):1184-1187. doi: 10.1016/j.jmii.2021.03.006. Epub 2021 Mar 23.
- Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423.
- Su NY, Shi Q, Mei H, Hu J, Liu YX, Liu HN, Liu HQ, Guo Y, Wang XW, Lan CH. Efficacy and safety of vonoprazan-based dual therapy and esomeprazole-based dual therapy in eradicating primary Helicobacter pylori infection: A propensity score matching analysis. Helicobacter. 2023 Oct;28(5):e13003. doi: 10.1111/hel.13003. Epub 2023 Aug 10.
- Shirai N, Sugimoto M, Kodaira C, Nishino M, Ikuma M, Kajimura M, Ohashi K, Ishizaki T, Hishida A, Furuta T. Dual therapy with high doses of rabeprazole and amoxicillin versus triple therapy with rabeprazole, amoxicillin, and metronidazole as a rescue regimen for Helicobacter pylori infection after the standard triple therapy. Eur J Clin Pharmacol. 2007 Aug;63(8):743-9. doi: 10.1007/s00228-007-0302-8. Epub 2007 Jun 13.
- Liu D, Wang J, Xie Y. Refractory Helicobacter pylori infection and the gastric microbiota. Front Cell Infect Microbiol. 2022 Sep 27;12:976710. doi: 10.3389/fcimb.2022.976710. eCollection 2022.
- Shirzad-Aski H, Besharat S, Kienesberger S, Sohrabi A, Roshandel G, Amiriani T, Norouzi A, Keshtkar A. Association Between Helicobacter pylori Colonization and Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2021 May-Jun 01;55(5):380-392. doi: 10.1097/MCG.0000000000001415.
- Tepler A, Narula N, Peek RM Jr, Patel A, Edelson C, Colombel JF, Shah SC. Systematic review with meta-analysis: association between Helicobacter pylori CagA seropositivity and odds of inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Jul;50(2):121-131. doi: 10.1111/apt.15306. Epub 2019 Jun 5.
- Ismail HF, Fick P, Zhang J, Lynch RG, Berg DJ. Depletion of neutrophils in IL-10(-/-) mice delays clearance of gastric Helicobacter infection and decreases the Th1 immune response to Helicobacter. J Immunol. 2003 Apr 1;170(7):3782-9. doi: 10.4049/jimmunol.170.7.3782.
- Ismail HF, Zhang J, Lynch RG, Wang Y, Berg DJ. Role for complement in development of Helicobacter-induced gastritis in interleukin-10-deficient mice. Infect Immun. 2003 Dec;71(12):7140-8. doi: 10.1128/IAI.71.12.7140-7148.2003.
- Chen W, Shu D, Chadwick VS. Helicobacter pylori infection: mechanism of colonization and functional dyspepsia Reduced colonization of gastric mucosa by Helicobacter pylori in mice deficient in interleukin-10. J Gastroenterol Hepatol. 2001 Apr;16(4):377-83. doi: 10.1046/j.1440-1746.2001.02459.x.
- Ye ZN, Xia HH, Zhang R, Li L, Wu LH, Liu XJ, Xie WR, He XX. The Efficacy of Washed Microbiota Transplantation on Helicobacter pylori Eradication: A Pilot Study. Gastroenterol Res Pract. 2020 Oct 19;2020:8825189. doi: 10.1155/2020/8825189. eCollection 2020.
- Brunse A, Martin L, Rasmussen TS, Christensen L, Skovsted Cilieborg M, Wiese M, Khakimov B, Pieper R, Nielsen DS, Sangild PT, Thymann T. Effect of fecal microbiota transplantation route of administration on gut colonization and host response in preterm pigs. ISME J. 2019 Mar;13(3):720-733. doi: 10.1038/s41396-018-0301-z. Epub 2018 Oct 26.
- de Klerk N, Maudsdotter L, Gebreegziabher H, Saroj SD, Eriksson B, Eriksson OS, Roos S, Linden S, Sjolinder H, Jonsson AB. Lactobacilli Reduce Helicobacter pylori Attachment to Host Gastric Epithelial Cells by Inhibiting Adhesion Gene Expression. Infect Immun. 2016 Apr 22;84(5):1526-1535. doi: 10.1128/IAI.00163-16. Print 2016 May.
- National Institute of Hospital Administration, NHC; Society of Parenteral and Enteral Nutrition, Chinese Medical Association; Intestinal Microecology Cooperative Group, Chinese Society for Parenteral and Enteral Nutrition. [Expert consensus on clinical application management of fecal microbiota transplantation (2022 edition)]. Zhonghua Wei Chang Wai Ke Za Zhi. 2022 Sep 25;25(9):747-756. doi: 10.3760/cma.j.cn441530-20220725-00324. Chinese.
- Gilca-Blanariu GE, Stefanescu G, Girleanu I, Iqbal T, Segal J, Mullish B, Quraishi MN, Keller J, Molnar T, Megraud F, Dumitrascu D, Manuc M, Iancu LS, Marica C, Gheorghe C, Manzoor S, Trifan A. Romanian National Guideline on Translating Fecal Microbiota Transplantation Applications related to Clostridioides difficile Infections into the Local Clinical Practice. J Gastrointestin Liver Dis. 2021 Mar 13;30(1):147-163. doi: 10.15403/jgld-3297.
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)
20. juli 2026
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
10. juli 2026
Først indsendt, der opfyldte QC-kriterier
10. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 20240507
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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