A multi-center prospective trial comparing Functional Dyspepsia patients with or without Metabolic Syndrome treated with omeprazole

A multi-center prospective trial comparing Functional Dyspepsia patients with or without Metabolic Syndrome treated with omeprazole - DMETS study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001974

Enrollment

210

Registered

2009-05-20

Start date

2009-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Functional Dyspepsia

Interventions

omeprazole

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with functional dyspepsia diagnosed according to the Rome III classification.

Exclusion criteria

Exclusion criteria: 1. Endoscopic finding such as reflux esophagitis (> grade A) and erosive gastritis. 2. Patients with past history of gastrectomy 3. NSAIDs or low-dose aspirin -related dyspepsia 4. Patients treated with proton pump inhibitors(PPI), H2 receptor antagonists(H2RAs), prokinetic drugs, anticholinergic drugs, antidepressant drugs, antianxiety drugs (within 14 days prior to the screening visit) 5. Patients with organic disease in the brain or with psychological disorders 6. Patients with alcoholics or with drug dependence 7. Severe endocrine disease including hyperthyroidism 8. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases 9. Drug allegy for omeprazole 10. Expectant mother, mother with breast-feeding 11. Other not applicable patients recognized by a doctor

Design outcomes

Primary

Measure	Time frame
Severity of dyspeptic symtoms by Gastrointestinal Symptom Rating Scale(GSRS)	—

Secondary

Measure	Time frame
Patients' Background QOL evaluation by SF-36 Anti-H. pylori IgG Serum pepsinogen I, pepsinogen II	—

Countries

Japan

Contacts

Public ContactMAMORU ITO, M.D., Ph.D.

Okayama Saiseikai General Hospital Internal Medicine

mitohxxx@gmail.com086-252-2211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026