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Evaluation of the effectiveness and safety of fecal microbiota transplantation in the treatment of refractory Helicobacter pylori infection: a multicenter controlled study

Evaluation of the effectiveness and safety of fecal microbiota transplantation in the treatment of refractory Helicobacter pylori infection: a multicenter controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101347
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory helicobacter pylori infection

Interventions

treatment group:fecal microbiota transplantation(FMT)

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-65 years old, male or female; 2. Positive rapid urea breath test, that is, a positive urea breath test within 2 weeks before or within 1 month after the visit, in which the 13C breath test result is higher than 4% or the 14C test result is higher than 100 Bq as the positive threshold; 3. Meet the diagnostic criteria for refractory Helicobacter pylori infection as defined in the "2022 Chinese Guidelines for the Treatment of Helicobacter Pylori Infection" issued by the Chinese Society of Gastroenterology; 4. The research participants or their guardians can fully understand the content of the informed consent of this trial and voluntarily sign the informed consent form; 5. Able to receive follow-up visits, follow-up examinations and collect specimens, including blood, urine and fecal samples, on time;

Exclusion criteria

Exclusion criteria: 1. Severe fever or serious infection within 7 days of enrollment; 2. Use of probiotics, prebiotics, antibiotics, bismuth or H2 receptor antagonists (H2RA), proton pump inhibitors (PPIs) or other drugs that may affect the intestinal flora within 3 months before treatment, or plan to use these drugs within the following 4 months; 3. Received FMT treatment in the past 12 months; 4. Previously diagnosed organic gastrointestinal diseases and serious gastrointestinal problems requiring immediate treatment, such as Hirschsprung's disease, intestinal perforation, intestinal bleeding, intestinal obstruction, intussusception, inflammatory bowel disease, celiac disease or eosinophilic esophagitis; 5. The patient also suffers from other serious diseases that affect the evaluation of this study, such as severe liver disease, severe immunodeficiency disease, heart disease, cerebrovascular disease, kidney disease, malignant tumor and alcoholism; 6. Those who are allergic to the drugs used in this study; 7. Those who have participated in other drug research within 3 months; 8. Pregnant or lactating women; 9. The patient is unable to express his symptoms and wishes correctly, and is unable to cooperate with the experimenter.

Design outcomes

Primary

MeasureTime frame
urea breath test;

Secondary

MeasureTime frame
urea breath test;16S rRNA sequencing;Serum and urine metabolic indexes;Gastrointestinal Symptom;Boston score;

Countries

China

Contacts

Public ContactMuHan Lv

The Affiliated Hospital of Southwest Medical University

lvmuhan@swmu.edu.cn+86 152 8309 9635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026