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Biological method for detection of Helicobacter pylori in children

Biological method for detection of Helicobacter pylori in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068459
Enrollment
Unknown
Registered
2023-02-20
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Hp infection

Interventions

Gold Standard:C13 breath test, histopathological diagnosis
Index test:Saliva or urine nucleic acid test for Hp

Sponsors

Ruijin Hospital Shangai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria of helicobacter pylori group :(1) Children diagnosed with helicobacter pylori infection according to the expert consensus on the diagnosis and treatment of helicobacter pylori infection in children; (2) Under the age of 14, both male and female; (3) Children who need endoscopy as determined by the clinician; (4) No contraindications of endoscopic examination; (5) Sign the informed letter. 2. Inclusion criteria of the control group :(1) Children who were not diagnosed with helicobacter pylori infection and were determined by clinicians to come to the hospital for endoscopy; (2) Under 14 years of age; (3) Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who could not complete endoscopy: (1) patients with severe heart disease such as arrhythmias, active heart infarction, and severe heart failure; (2) Severe lung diseases: asthma, respiratory failure, unable to lie flat; (3) Patients with severe hypertension, mental illness and obvious disturbance of consciousness cannot cooperate; (4) Acute perforation of esophagus, stomach and duodenum; (5) Severe acute intestinal infection; (6) Patients with coagulopathy and bleeding tendency; (7) Severe spinal deformity; 2. H2 receptor antagonists or PPI inhibitors were used within 2 weeks before the study, and antibiotics and bismuth were used within 4 weeks; 3. Refusal or failure to perform endoscopy or biopsy.

Design outcomes

Primary

MeasureTime frame
nucleic acid of Hp;C13 breath test;histopathological test for Hp;susceptibility;Specificity;accuracy;

Countries

China

Contacts

Public ContactChundi Xu

Ruijin Hospital Shangai Jiaotong University School of Medicine

chundixu55@126.com+86 189 1776 2267

Outcome results

None listed

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