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

July 10, 2026 updated by: Gao Caiping, Sichuan Provincial People's Hospital
To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gao Caiping, Doctor
  • Phone Number: 17708130286
  • Email: gaocaip@126.com

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 601172
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: washed microbiota
Study on the effect of washed microbiota transplantation on eradication of refractory Helicobacter pylori infection.
Biological: transanal fecal bacteria transplant
Received transanal fecal bacteria transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whether Hp is successfully eradicated
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20240507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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