Study on the Effect of Fecal Microbiota Transplantation on Eradication of Refractory Helicobacter Pylori Infection

NCT07704255 | Recruiting Phase 4

• 1 other identifier: 20240507
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.

Conditions

Helicobacter Pylori Infection

Keywords

washed microbiota

Outcome Measures

Primary Outcomes (1)

• Whether Hp is successfully eradicated

  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

Study Arms (1)

washed microbiota

EXPERIMENTAL

Study on the effect of washed microbiota transplantation on eradication of refractory Helicobacter pylori infection.

Biological: transanal fecal bacteria transplant

Interventions

transanal fecal bacteria transplant BIOLOGICAL

Received transanal fecal bacteria transplant

washed microbiota

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Ages 18-70
• \. Hp infection treatment failed ≥4 times with guidelines-recommended therapies
• \. Patients with early gastric cancer, peptic ulcer, gastric MALT lymphoma, atrophic gastritis and other diseases requiring the eradication of Hp.

You may not qualify if:

• \. 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;
• \. Pregnant or lactating women;
• \. Those who are allergic to the investigational drugs used in this test or have contraindications;
• \. Participated in other drug trials within 3 months before the treatment of this trial;
• \. 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;
• \. Subjects with dysphagia;
• \. Patients with malignant tumors, serious concomitant diseases, severe ulcer bleeding or perforation;
• \. Patients judged by the investigator to be unsuitable for clinical trials.
• \. Those who do not want to sign the informed consent for the study.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 601172, China

RECRUITING

Related Publications (18)

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  PMID: 37565458 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 33723543 BACKGROUND

Central Study Contacts

Gao Caiping, Doctor

CONTACT

17708130286; gaocaip@126.com

Xia Yuehan, Master

CONTACT

13438917607; 694159760@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CN (1)