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IRCT138802071852N1 IRCT 2009-08-11 Digestive Disease Research Center, Tehran University of Medical Sciences 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 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 2001-05-22 anticipated 600 Complete https://irct.ir/trial/1431 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Interruption of study was planned, when the aim (progression of atrophy or intestinal metaplasia under placebo and regression under eradication by 15%) was achieved at 2 years. No continuation of study will be performed up to 4 years. N/A Gastric precancerous lesions. Intervention 1: Omeprazole (2×20 mg, daily in 2 doses), Bismuth subcitrate (4×120 mg, daily in 2 doses), Furazolidone (4×100 mg, daily in 2 doses), Metronidazole (4×250 mg, daily in 2 doses). Intervention 2: Placebo tablets for colloidal Bismuth subcitrate, QID for 2 weeks, Placebo tablet for Furazolidone, QID 1 week, Placebo tablet for Metronidazole, QID for 2 weeks, Placebo caps for Omeprazole, BID for 2 weeks.
public Prof. Sadegh Massarrat
Iran (Islamic Republic of) +98 21 8241 5104 massarrat@ams.ac.ir Digestive Disease Research Center, TUMS scientific Prof Sadegh Massarrat
Digestive Disease Research Center, Shariati Hospital
Tehran Iran (Islamic Republic of) +98 21 8241 5104 massarrat@ams.ac.ir Digestive Disease Research Center, TUMS Iran (Islamic Republic of) 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) 40 years 65 years Both K31.9 Disease of stomach and duodenum, unspecified Treatment - Drugs Placebo Omeprazole (2×20 mg, daily in 2 doses), Bismuth subcitrate (4×120 mg, daily in 2 doses), Furazolidone (4×100 mg, daily in 2 doses), Metronidazole (4×250 mg, daily in 2 doses). Placebo tablets for colloidal Bismuth subcitrate, QID for 2 weeks, Placebo tablet for Furazolidone, QID 1 week, Placebo tablet for Metronidazole, QID for 2 weeks, Placebo caps for Omeprazole, BID for 2 weeks 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. 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. Digestive Disease Research Center, Tehran University of Medical Sciences Approved 2000-02-20 Ethics committee: Digestive Disease Research Center Shariati Hospital Tehran Iran (Islamic Republic of)