Esomeprazole Treatment for Patients With Lymphocytic Gastritis (LYNEX)

Technische Universität Dresden

Status and phase

Unknown

Phase 3

Conditions

Lymphocytic Gastritis

Treatments

Drug: Esomeprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00455754

LYNEX

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis

Full description

Recently, a placebo controlled trial of our group has shown that H. pylori eradication therapy consisting of omeprazole 20 mg bid, clarithromycin 500 mg bid, amoxicillin 1000 mg bid for seven days leads to a complete long-lasting resolution of lymphocytic gastritis in 96 % of patients. However, after 3 months we also found a healing rate of 50 % in patients who received omeprazole 20 mg bid and placebo antibiotics for seven days suggesting spontaneous remission or a potential PPI effect. Thus, we speculate that PPI therapy may have led to elimination of H. pylori and subsequently healing of lymphocytic gastritis in those patients with potentially minimal H. pylori colonization at baseline. For this reason we investigate whether a PPI treatment alone is able to heal patients with lymphocytic gastritis.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven lymphocytic gastritis (IEL > 25/100)
Male or female aged 18 years or older
Signed and written informed consent

Exclusion criteria

Regular NSAID or aspirin intake
Concomitant medication with antibiotics, bismuth subsalicylate, aminosalicylates
Regular PPI therapy
Treatment with ketoconazole or other CYP3A inhibitors
previous surgery of the stomach
known or suspected hypersensitivity to esomeprazole
Malignant diseases
Concomitant severe diseases
Pregnancy or lactation
Contraindication to take biopsies (Quick < 50%, PTT > 50 s, thrombocytes < 100.000/mm3)