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Multi-omics study of gut microbiota before and after Helicobacter pylori eradication therapy

Multi-omics study of gut microbiota before and after Helicobacter pylori eradication therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108947
Enrollment
Unknown
Registered
2025-09-09
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Helicobacter pylori infection

Interventions

Hp negative control group:None
Test Group-A:Iprazole 5mg (twice a day, taken orally 0.5 hours before meals), amoxicillin 1g (twice a day, taken orally immediately after meals), clarithromycin 500mg (twice a day, taken orally immedi
Test Group-B:Alprazole 10mg (twice a day, taken orally 0.5 hours before meals) and amoxicillin 1g (three times a day, taken orally immediately after meals) for a course of 14 days.

Sponsors

Beijing Huaxin Hospital (The First Hospital of Tsinghua University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. H. pylori infection: Age 18-60 years old. (1) At least one of the following tests, including 13C-urea breath test, histopathology, bacterial culture, and rapid urease test, is positive; (2) Hp infection first-time patients; (3) Be fully informed and agree to participate in this study. 2. Hp negative: Age 18-60 years old. (1) Healthy people with negative Hp test results and matched with age and gender (confirmed by 13C-urea breath test); (2) No use of antibiotics, probiotics, gastric acid suppression drugs, or other drugs that affect intestinal flora in the past 4 weeks; (3) Be fully informed and agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Previous history of H. pylori infection and treatment; 2. Use of antibiotics, probiotics, gastric acid secretion suppressing drugs and other drugs that affect intestinal flora within 4 weeks before the start of treatment; 3. A history of allergy or contraindications to the drugs used in this clinical trial; 4. Patients with a history of other digestive system diseases, digestive tract surgery, or obvious digestive tract structural abnormalities; 5. The presence of diseases or clinical conditions that may interfere with the evaluation of research treatment, such as liver and kidney disease, cardiopulmonary insufficiency, cerebrovascular disease, mental illness, malignant tumor, etc.; 6. Pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Differences in fecal intestinal flora metabolomics and metagenomics between the experimental group before eradication treatment and the control group;Comparison of metagenomics and metabolomics of intestinal flora in the experimental group before eradication therapy (week 0) and after successful eradication therapy (week 6);Proteomic and transcriptomic results of gastric mucosal tissue in the experimental and control groups;Comparison of the gut microbiota (6 weeks) metagenomics and metabolomics between the control group and experimental group B after successful eradication therapy.;Comparison of the gut microbiota (6 weeks) metagenomics and metabolomics between the control group and experimental group A after successful eradication therapy.;

Secondary

MeasureTime frame
Results of 13C-urea breath test in the experimental group 4 weeks after treatment;

Countries

China

Contacts

Public ContactCheng Yanli

Beijing Huaxin Hospital (The First Hospital of Tsinghua University)

chengyanli001@126.com+86 10 6430 8543

Outcome results

None listed

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