Clinical trial NCT00455754: Esomeprazole Treatment for Patients With Lymphocytic Gastritis
Official title: Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphocytic Gastritis
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The primary objective is to assess the healing rate of
measure: patients with lymphocytic gastritis irrespective of H. pylori status after treatment
measure: with esomeprazole 20 mg twice daily for 2 weeks.
Secondary outcomes:
measure: Secondary objective of the study are to evaluate the grade and activity of gastritis before and after
measure: treatment according to updated Sydney classification, to assess the clinical GI symptoms at baseline and after 3 months
measure: and to evaluate influence of the H. pylori-Status
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medical Department I, University Hospital Carl Gustav Carus, Technical University
Study officials:
affiliation: Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
name: Ahmed Madisch, MD
role: PRINCIPAL_INVESTIGATOR
References: