Evaluation of effectiveness of H.pylori eradication on regression of gastric precancerous lesions in the first degree relatives of patients with gastric cancer. A long term double blind randomized controlled clinical trial

Not Applicable

• Conditions: Gastric precancerous lesions.; Disease of stomach and duodenum, unspecified

• Registration Number: IRCT138802071852N1
• Lead Sponsor: Digestive Disease Research Center, Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

First degree relatives of gastric cancer patients, age between 40 and 65 years, presence of diffuse gastritis, positive urease test
Exclusion criteria: significant lesions in stomach (ulcer, diffuse gastric erosions or erosive duodenits, gastric neoplasia or severe dysplasia verified by histology), negative Helicobacter Pylori (Negative urease test and no H. Pylori in all specimens by histology)

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Course of progression or regression of gastric atrophy and intestinal metaplasia under eradication or placebo treatment. Timepoint: Blood taking, 6 months and 2 and 4 years after first endoscopy and control endoscopy 2 and 4 years after start of trial. Method of measurement: Upper GI endoscopy and taking biopsies from different gastric areas 2 and 4 years after start of study and blood taking before first endoscopy, 6 months and 2 and 4 years after eradication or placebo treatment for determination of H.Pylori antibody and other biomarkers.

Secondary Outcome Measures

Name	Time	Method
H.pylori eradication and regression of precancerous lesions (atrophy and intestinal metaplasia) under treatment and progression of precancerous lesions in placebo group. Timepoint: 2 and 4 years. Method of measurement: Endoscopy and evaluation of histology according to Sidney classification after 2 and 4 years after begin of study.