Importance of Cytokines in Peptic Ulcer Disease: Implications for Treatment

NCT00534443 | Completed Phase 4 DMC

• 1 other identifier: 3530
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peptic Ulcer

Keywords

peptic ulcer; gastritis; sTREM-1; cytokines; Changes of inflammatory status in gastric mucosa; sTREM-1 as a disease marker

Outcome Measures

Primary Outcomes (1)

• Effect of treatment on changes of cytokines levels in serum of patients

  Baseline and 8 weeks

Secondary Outcomes (1)

• Effect of treatment on changes of cytokines levels in supernatants of cultures of gastric mucosa

  Baseline and 8 weeks

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Endoscopy of upper GI tract PROCEDURE

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.

Also known as: Gastroscopy

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Department of Endoscopy, Sismanoglion General Hospital

Athens, 151 26, Greece

Location

Related Publications (3)

• Tzivras M, Koussoulas V, Giamarellos-Bourboulis EJ, Tzivras D, Tsaganos T, Koutoukas P, Giamarellou H, Archimandritis A. Role of soluble triggering receptor expressed on myeloid cells in inflammatory bowel disease. World J Gastroenterol. 2006 Jun 7;12(21):3416-9. doi: 10.3748/wjg.v12.i21.3416.

  PMID: 16733861 BACKGROUND

• Koussoulas V, Vassiliou S, Demonakou M, Tassias G, Giamarellos-Bourboulis EJ, Mouktaroudi M, Giamarellou H, Barbatzas C. Soluble triggering receptor expressed on myeloid cells (sTREM-1): a new mediator involved in the pathogenesis of peptic ulcer disease. Eur J Gastroenterol Hepatol. 2006 Apr;18(4):375-9. doi: 10.1097/00042737-200604000-00010.

  PMID: 16538108 BACKGROUND

• Koussoulas V, Giamarellos-Bourboulis EJ, Barbatzas C, Pimentel M. Serum sTREM-1 as a surrogate marker of treatment outcome in patients with peptic ulcer disease. Dig Dis Sci. 2011 Dec;56(12):3590-5. doi: 10.1007/s10620-011-1761-4. Epub 2011 Jun 2.

  PMID: 21633832 DERIVED

MeSH Terms

Conditions

Peptic Ulcer; Gastritis

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Evangelos J. Giamarellos-Bourboulis, MD, PhD

  4th Department of Internal Medicine, ATTIKON University Hospital, 124 62 Athens, Greece

  STUDY CHAIR

• Vassileios Koussoulas, MD, PhD

  Department of Endoscopy, Sismanoglion General Hospital, 151 26 Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 24, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 9, 2011

Record last verified: 2008-06

Locations

GR (1)