|
|
|
|
|
|
Sponsored by: |
University of Athens |
Information provided by: | University of Athens |
ClinicalTrials.gov Identifier: | NCT00534443 |
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 esomaprazole 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 |
Peptic Ulcer |
Procedure: Endoscopy of upper GI tract |
MedlinePlus related topics: | Endoscopy Peptic Ulcer |
ChemIDplus related topics: | Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium E 3810 Proline |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
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 |
Estimated Enrollment: | 130 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | May 2008 |
Groups/Cohorts | Assigned Interventions |
1: Case
A total of 130 patients with peptic ulcer disease and /or chronic gastritis will be enrolled in the study after written informed consent
|
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. |
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 esomaprazole 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Evangelos J Giamarellos-Bourboulis, MD, PhD | 00302105831000 ext 994 | giamarel@ath.forthnet.gr |
Contact: Vassileios Koussoulas, MD, PhD | 00302108101401 | kous73@yahoo.gr |
Greece | |||||
Department of Endoscopy, Sismanoglion General Hospital | Recruiting | ||||
Athens, Greece, 151 26 | |||||
Contact: Vassileios Koussoulas, MD, PhD 00302108039111 ext 798 kous73@yahoo.gr | |||||
Principal Investigator: Vassileios Koussoulas, MD, PhD |
University of Athens |
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 |
Study ID Numbers: | 3530 |
First Received: | September 21, 2007 |
Last Updated: | September 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00534443 |
Health Authority: | Greece: National Organization of Medicines |
|
|
|
|
|