CompletedPhase 4

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

China140 participantsStarted 2022-04-01

Plain-language summary

Gastric intestinal metaplasia significantly increases the risk of gastric cancer. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested to have a suppressive effect on tumorigenesis and cancer cell growth. The investigators devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against gastric intestinal metaplasia and the safety of this drug in non-diabetic gastric intestinal metaplasia patients.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients aged from 18 to 75 years old;
✓. Body mass index (BMI) ranged from 18.5 to 23.9 at enrollment;
✓. IM patients with OLGIM stage Ⅱ-Ⅲ diagnosed by upper gastrointestinal endoscopy and histopathological biopsy within the last 3 months;
✓. Patients without H. pylori infection confirmed by 13C-urea breath test (UBT) or patients with H. pylori infection who completed the bismuth-containing quadruple program and had confirmed successful eradication by 13C-UBT.

Exclusion criteria

✕. History of diabetes mellitus (use of medication and/or HbA1c over 6.5%);
✕. History of regular use (defined as at least once per week) of NSAIDs and/or aspirin;
✕. History of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor;
✕. History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure;
✕. Patients with contraindications or allergies to the drugs in this study;
✕. Breastfeeding or pregnancy;
✕. History of substance abuse or alcohol abuse in the past 1 year;
✕. Severe mental illness;

What they're measuring

Rate of reversal and progression of gastric intestinal metaplasia

Timeframe: 6 months

Trial details

NCT IDNCT05288153

SponsorXijing Hospital of Digestive Diseases

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Gastric Intestinal Metaplasia trials