Effect of PPIs on Stool DNA Test for H. Pylori

Официальное название

Effect of Proton Pump Inhibitors on Stool DNA Detection of Helicobacter Pylori: A Prospective Clinical Study

Обзор

This prospective, self-controlled clinical study aims to evaluate the impact of proton pump inhibitor (PPI) use on the accuracy of stool DNA testing for Helicobacter pylori (H. pylori) and to assess the applicability of this test in patients receiving PPI therapy. Patients requiring long-term PPI treatment and meeting the inclusion criteria were enrolled. After at least four weeks of PPI therapy, a stool DNA test was performed, along with collection of gastric mucosal samples via gastroscopy for tissue PCR, histology, and rapid urease testing, as well as H. pylori antibody detection. Subsequently, PPI treatment was discontinued for four weeks, after which a 13C-urea breath test and a repeat stool DNA test were conducted. By comparing the sensitivity, specificity, and consistency of stool DNA testing before and after PPI discontinuation, this study aims to characterize the interference of PPIs with the test results, thereby providing evidence to support improvements in H. pylori diagnostic methods.

Вмешательства

• Препарат Proton Pump Inhibitor Discontinuation
  Participants underwent stool DNA testing and endoscopic evaluation after at least 4 weeks of continuous proton pump inhibitor (PPI) therapy. Subsequently, PPI treatment was discontinued for 4 weeks, after which a 13C-urea breath test and a repeat stool DNA test were performed. The intervention involves a 4-week washout period of PPI to assess its interference with stool DNA detection of Helicobacter pylori.

Первичные конечные точки

• Change in Diagnostic Sensitivity and Specificity of Stool DNA Test Before and After PPI Discontinuation [Срок оценки: Assessed at two time points: at baseline (after ≥4 weeks of PPI use) and at 4 weeks after PPI discontinuation]

Вторичные конечные точки (1)

• Inter-Method Agreement Among Diagnostic Tests [Срок оценки: Baseline (for comparisons involving biopsy-based methods and serology) and 4 weeks after PPI discontinuation (for comparisons involving UBT)]

Критерии участия

Критерии включения

• Male or female patients aged 18-80 years;
• No prior H. pylori eradication therapy;
• Patients requiring proton pump inhibitor (PPI) therapy in the near future due to gastritis, peptic ulcer disease, or other indicated conditions;
• Patients with at least two positive results among H. pylori antibody test, histology, and rapid urease test (RUT);
• Provision of signed informed consent and being informed of the specific study protocol.

Критерии исключения

• Prior H. pylori eradication therapy;
• Pregnant or lactating women;
• Acute gastrointestinal bleeding;
• History of subtotal gastrectomy;
• Severe dysfunction of vital organs (heart, liver, kidney, lungs, etc.) or congenital diseases, such as class IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.;
• Refusal of enrollment by the guardian or the patient;
• Alcohol and/or drug abuse (addiction or dependence), or poor compliance as judged by the investigator;
• Individuals without legal capacity or with impaired insight;
• Abnormal neurological signs on physical examination;
• Use of oral antibiotics with bactericidal activity against H. pylori within 4 weeks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Шанхай

Идентификаторы

NCT: NCT07516262 · rjyg20260331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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