Importance of Cytokines in Peptic Ulcer Disease: Implications for Treatment

This study has been completed.
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT00534443
First received: September 21, 2007
Last updated: August 8, 2011
Last verified: June 2008
  Purpose

Although all PPIs are effective, there are some differences in their clinical performance, particularly in terms of the degree and speed of gastric acid suppression. Few data are also available about their effect of the pathophysiological mechanisms of gastritis and peptic ulcer disease. Aim of the present study is to investigate the effect of therapy with esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on the pattern of release of pro- and anti- inflammatory cytokines associated to peptic ulcerative process by the gastric mucosa.


Condition Intervention Phase
Peptic Ulcer
Procedure: Endoscopy of upper GI tract
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Clinical Study of the Efficacy of Esomeprazole or Rabeprazole on the Pattern of Release of Pro- and Anti-inflammatory Cytokines From Gastric Mucosa of Patients With Peptic Ulcer Disease

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Effect of treatment on changes of cytokines levels in serum of patients [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of treatment on changes of cytokines levels in supernatants of cultures of gastric mucosa [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
A total of 130 patients with peptic ulcer disease and /or chronic gastritis will be enrolled in the study after written informed consent. Patients will be prescribed oral treatment with rabeprazole or esomeprazole according to standard guidelines. Rabeprazole is administered 20mg twice daily and esomeprazole 10 mg once daily. Selection of rabeprazole or esomeprazole is at the discretion of the attending physicians. The drug is administered for four weeks in patients with duodenal ulcers, for eight weeks in patients with gastric ulcers and for four weeks in patients with chronic gastritis.
Procedure: Endoscopy of upper GI tract

Upper GI endoscopy, one time on diagnosis and a second time 15 days after the end of the treatment. Gastric juice will be aspirated immediately after the entrance of the endoscope into the gastric lumen. Four biopsy specimens will be obtained from adjacent areas of the gastric antrum. Each biopsy will be used for in vitro culture. Blood will be sampled from one antecubital vein under aseptic conditions.

Each patient will be given antisecretory treatment and - if necessary- eradication treatment of H. pylori according to international guidelines.

Other Name: Gastroscopy

Detailed Description:

Although all PPIs are effective, there are some differences in their clinical performance, particularly in terms of the degree and speed of gastric acid suppression. Few data are also available about their effect of the pathophysiological mechanisms of gastritis and peptic ulcer disease.

Triggering receptor expressed on myeloid cells (TREM)-1 is a recently discovered receptor expressed on the surface of neutrophils and monocytes. Engagement of TREM-1 has been reported to trigger the synthesis of proinflammatory cytokines. A soluble form of TREM-1, named sTREM-1, was observed and identified at significant levels in serum samples from patients with disease of the gastrointestinal tract inflammatory bowel disease. rendering interest about the implication of sTREM-1 in their pathogenesis.

sTREM-1 was also found elevated in the gastric juice of patients with peptic ulcer disease being correlated to the degree of the infiltration of the gastric mucosa by neutrophils.

Published data of our group elicit that sTREM-1 secretion is a crucial parameter for evolution from chronic gastritis to peptic ulcer disease. Samples of biopsies of gastric mucosa were cultured in the absence/presence of endotoxins showing that the inflamed mucosa was a potent secretor of sTREM-1 whatever ceased to exist post-antisecretory treatment.

Aim of the present study is to investigate the effect of therapy with esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on the pattern of release of pro- and anti- inflammatory cytokines associated to peptic ulcerative process by the gastric mucosa.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Abdominal pain or discomfort and/or
  • Epigastric pain with nausea and vomiting and/or
  • Dyspepsia.

Exclusion Criteria:

  • Recent upper GI bleeding
  • Gastric carcinoma
  • Diabetes mellitus
  • Liver cirrhosis
  • Acute or chronic renal failure
  • The ingestion of any antimicrobial or antisecretory medication for at least 15 days prior to endoscopy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534443

Locations
Greece
Department of Endoscopy, Sismanoglion General Hospital
Athens, Greece, 151 26
Sponsors and Collaborators
University of Athens
Investigators
Study Chair: Evangelos J. Giamarellos-Bourboulis, MD, PhD 4th Department of Internal Medicine, ATTIKON University Hospital, 124 62 Athens, Greece
Principal Investigator: Vassileios Koussoulas, MD, PhD Department of Endoscopy, Sismanoglion General Hospital, 151 26 Athens, Greece
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evangelos Giamarellos-Bourboulis, University of Athens, Medical School, Greece
ClinicalTrials.gov Identifier: NCT00534443     History of Changes
Other Study ID Numbers: 3530
Study First Received: September 21, 2007
Last Updated: August 8, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Athens:
peptic ulcer
gastritis
sTREM-1
cytokines
Changes of inflammatory status in gastric mucosa
sTREM-1 as a disease marker

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Rabeprazole
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014