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A study on individualized eradication therapy of Helicobacter pylori based on detection of clarithromycin 23S rRNA resistance genotypes.

A study on individualized eradication therapy of Helicobacter pylori based on detection of clarithromycin 23S rRNA resistance genotypes.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083028
Enrollment
Unknown
Registered
2024-04-15
Start date
2024-04-19
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Helicobacter pylori infection

Interventions

Clarithromycin personalised treatment group:Perform clarithromycin 23S rRNA resistance gene detection using disk diffusion method for drug sensitivity cultivation. For subjects who are sensitive (with
The PCR resistance gene test results showed that the subjects were resistant (mutated) to tetracycline 0.5g tid+amoxicillin 1g bid+rabeprazole 10mg bid+bismuth potassium citrate 220mg bid quadruple th
Empirical bismuth quadruple group:Perform clarithromycin 23S rRNA resistance gene testing and disk diffusion method drug sensitivity culture testing, but both were given a combination therapy of clari

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65, regardless of gender; 2. Confirmed H. pylori infection by ^13C urea breath test, and deemed in need of H. pylori eradication therapy by a physician; 3. No history of prior H. pylori eradication therapy; willing to undergo H. pylori eradication treatment and participate in follow-up evaluations of eradication efficacy under the guidance of a physician; 4. Scheduled for esophagogastroduodenoscopy (EGD); 5. Medical history: No history of gastrointestinal, hepatic, pancreatic, or other digestive system diseases; no history of cardiovascular, respiratory, endocrine, renal, hematological, or other systemic diseases; no recent history of infectious diseases within the past month; 6. Medication history: No intake of the following medications within the month prior to specimen collection: a. Antibiotics (oral, intramuscular, or intravenous); b. Probiotics (various probiotics, prebiotics, and synbiotics); c. Gastric acid suppressants (proton pump inhibitors and H2 receptor antagonists); d. Cytokines, immunosuppressants, and cytotoxic agents; e. Hormones; f. Other medications affecting gastric microbiota; g. Bismuth preparations. 7. Subjects must sign an informed consent form after understanding the purpose, risks, and benefits of the trial.

Exclusion criteria

Exclusion criteria: 1. Severe organic diseases of the digestive system, such as digestive tract malignancies, gastrointestinal bleeding, perforated/obstructive peptic ulcers, intestinal obstruction, inflammatory bowel disease, etc.; 2. Systemic diseases that may affect eradication therapy, including severe cardiovascular diseases, diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological disorders, etc.; 3. History of abdominal surgery (excluding appendectomy and cesarean section); 4. Pregnant or lactating women, and subjects planning pregnancy in the near future; 5. Individuals legally classified as disabled (blind, deaf, mute, intellectual disability, mental disorder, physical disability); 6. Suspected or confirmed history of alcohol or substance abuse disorder; 7. Use of medications affecting gastrointestinal microbiota within the month prior to specimen collection: a. Antibiotics (oral, intramuscular, or intravenous); b. Probiotics (various probiotics, prebiotics, and synbiotics); c. Gastric acid suppressants (proton pump inhibitors and H2 receptor antagonists); d. Cytokines, immunosuppressants, and cytotoxic agents; e. Hormones; f. Other medications affecting gastrointestinal microbiota. 8. Subjects with allergies to the study medications; RUT-negative subjects. 9. History of prior H. pylori eradication therapy.

Design outcomes

Primary

MeasureTime frame
H. Pylori eradication rate;

Secondary

MeasureTime frame
subject compliance;adverse reaction;

Countries

China

Contacts

Public ContactDu Yiqi

Shanghai Changhai Hospital

duyiqi@hotmail.com+86 138 0199 3592

Outcome results

None listed

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