FindTrial
Sign In

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT138802071852N1
Enrollment
600
Registered
2009-08-11
Start date
2001-05-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Gastric precancerous lesions. Disease of stomach and duodenum, unspecified

Interventions

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). Interven
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

Sponsors

Digestive Disease Research Center, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Sadegh Massarrat

Digestive Disease Research Center, TUMS

massarrat@ams.ac.ir+98 21 8241 5104

Outcome results

None listed

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