search
Back to results

Helicobacter Pylori Empiric Treatment in Ulcer Bleeding (HETUB)

Primary Purpose

Peptic Ulcer Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Empirical Hp eradication
Eradication treatment guided by a positive test
Sponsored by
Hospital de Sabadell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer Hemorrhage focused on measuring Helicobacter pylori, Treatment, Upper gastrointestinal bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18.
  • Informed Consent signed.
  • Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer.
  • Life expectancy longer than 6 months.
  • Able to attend further clinical controls.
  • Absence of the following exclusion criteria.

Exclusion Criteria:

  • Previous eradication treatment.
  • Use of antibiotics 2 weeks prior to inclusion.
  • Need for Antisecretor treatment that cannot be stopped to perform the breath test.
  • Pregnancy or breastfeeding.

Sites / Locations

  • Hospital de Sabadell, Institut Universitari Parc TauliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Empirical eradication treatment

Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology).

Outcomes

Primary Outcome Measures

Helicobacter pylori eradication rate

Secondary Outcome Measures

Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.

Full Information

First Posted
May 27, 2008
Last Updated
July 7, 2009
Sponsor
Hospital de Sabadell
Collaborators
Corporacion Parc Tauli, Consorcio Centro de Investigación Biomédica en Red (CIBER)
search

1. Study Identification

Unique Protocol Identification Number
NCT00687336
Brief Title
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding
Acronym
HETUB
Official Title
Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Sabadell
Collaborators
Corporacion Parc Tauli, Consorcio Centro de Investigación Biomédica en Red (CIBER)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Hemorrhage
Keywords
Helicobacter pylori, Treatment, Upper gastrointestinal bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Empirical eradication treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology).
Intervention Type
Other
Intervention Name(s)
Empirical Hp eradication
Other Intervention Name(s)
Standard Hp eradication treatment
Intervention Description
Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
Intervention Type
Other
Intervention Name(s)
Eradication treatment guided by a positive test
Other Intervention Name(s)
Standard Hp treatment
Intervention Description
Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Time Frame
two years
Secondary Outcome Measure Information:
Title
Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18. Informed Consent signed. Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer. Life expectancy longer than 6 months. Able to attend further clinical controls. Absence of the following exclusion criteria. Exclusion Criteria: Previous eradication treatment. Use of antibiotics 2 weeks prior to inclusion. Need for Antisecretor treatment that cannot be stopped to perform the breath test. Pregnancy or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pilar Garcia, Dra.
Phone
34-93-723-1010
Ext
20101
Email
pgarciai@telefonica.net
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Calvet, Dr.
Phone
34-93-723-1010
Ext
20101
Email
xcalvet@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Garcia, Dra.
Organizational Affiliation
Hospital de Sabadell
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xavier Calvet, Dr.
Organizational Affiliation
Hospital de Sabadell
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Sabadell, Institut Universitari Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
7982436
Citation
Calam J. Helicobacter pylori. Eur J Clin Invest. 1994 Aug;24(8):501-10. doi: 10.1111/j.1365-2362.1994.tb01099.x. No abstract available.
Results Reference
background
PubMed Identifier
7777803
Citation
Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. doi: 10.3109/00365529509107760.
Results Reference
background
PubMed Identifier
15887152
Citation
Houghton J, Wang TC. Helicobacter pylori and gastric cancer: a new paradigm for inflammation-associated epithelial cancers. Gastroenterology. 2005 May;128(6):1567-78. doi: 10.1053/j.gastro.2005.03.037.
Results Reference
background
PubMed Identifier
8547530
Citation
Kuipers EJ, Thijs JC, Festen HP. The prevalence of Helicobacter pylori in peptic ulcer disease. Aliment Pharmacol Ther. 1995;9 Suppl 2:59-69.
Results Reference
background
PubMed Identifier
10091208
Citation
Gisbert JP, Boixeda D, Aller R, de la Serna C, Sanz E, Martin de Argila C, Abraira V, Garcia Plaza A. [Helicobacter pylori and digestive hemorrhage due to duodenal ulcer: the prevalence of the infection, the efficacy of 3 triple therapies and the role of eradication in preventing a hemorrhagic recurrence]. Med Clin (Barc). 1999 Feb 13;112(5):161-5. Spanish.
Results Reference
background
PubMed Identifier
10573377
Citation
Gisbert JP, Blanco M, Mateos JM, Fernandez-Salazar L, Fernandez-Bermejo M, Cantero J, Pajares JM. H. pylori-negative duodenal ulcer prevalence and causes in 774 patients. Dig Dis Sci. 1999 Nov;44(11):2295-302. doi: 10.1023/a:1026669123593.
Results Reference
background
PubMed Identifier
1987878
Citation
Soll AH, Weinstein WM, Kurata J, McCarthy D. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991 Feb 15;114(4):307-19. doi: 10.7326/0003-4819-114-4-307.
Results Reference
background
PubMed Identifier
8058080
Citation
Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. doi: 10.1056/NEJM199409153311107. No abstract available.
Results Reference
background
PubMed Identifier
2890019
Citation
Coghlan JG, Gilligan D, Humphries H, McKenna D, Dooley C, Sweeney E, Keane C, O'Morain C. Campylobacter pylori and recurrence of duodenal ulcers--a 12-month follow-up study. Lancet. 1987 Nov 14;2(8568):1109-11. doi: 10.1016/s0140-6736(87)91545-5.
Results Reference
background
PubMed Identifier
2904568
Citation
Marshall BJ, Goodwin CS, Warren JR, Murray R, Blincow ED, Blackbourn SJ, Phillips M, Waters TE, Sanderson CR. Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori. Lancet. 1988 Dec 24-31;2(8626-8627):1437-42. doi: 10.1016/s0140-6736(88)90929-4.
Results Reference
background
PubMed Identifier
8284627
Citation
Graham DY, Hepps KS, Ramirez FC, Lew GM, Saeed ZA. Treatment of Helicobacter pylori reduces the rate of rebleeding in peptic ulcer disease. Scand J Gastroenterol. 1993 Nov;28(11):939-42. doi: 10.3109/00365529309098288.
Results Reference
background
PubMed Identifier
7698617
Citation
Rokkas T, Karameris A, Mavrogeorgis A, Rallis E, Giannikos N. Eradication of Helicobacter pylori reduces the possibility of rebleeding in peptic ulcer disease. Gastrointest Endosc. 1995 Jan;41(1):1-4. doi: 10.1016/s0016-5107(95)70266-0.
Results Reference
background
PubMed Identifier
9647020
Citation
Macri G, Milani S, Surrenti E, Passaleva MT, Salvadori G, Surrenti C. Eradication of Helicobacter pylori reduces the rate of duodenal ulcer rebleeding: a long-term follow-up study. Am J Gastroenterol. 1998 Jun;93(6):925-7. doi: 10.1111/j.1572-0241.1998.00278.x.
Results Reference
background
PubMed Identifier
15230669
Citation
Castro-Fernandez M, Sanchez-Munoz D, Garcia-Diaz E, Miralles-Sanchiz J, Vargas-Romero J. Diagnosis of Helicobacter pylori infection in patients with bleeding ulcer disease: rapid urease test and histology. Rev Esp Enferm Dig. 2004 Jun;96(6):395-8; 398-401. doi: 10.4321/s1130-01082004000600005. English, Spanish.
Results Reference
background
PubMed Identifier
16494583
Citation
Gisbert JP, Abraira V. Accuracy of Helicobacter pylori diagnostic tests in patients with bleeding peptic ulcer: a systematic review and meta-analysis. Am J Gastroenterol. 2006 Apr;101(4):848-63. doi: 10.1111/j.1572-0241.2006.00528.x. Epub 2006 Feb 22.
Results Reference
background
PubMed Identifier
16159556
Citation
Gisbert JP, Calvet X, Gomollon F, Mones J; Grupo Conferencia Espanola de Consenso sobre Helicobacter pylori. [Eradication treatment of Helicobacter pylori. Recommendations of the II Spanish Consensus Conference]. Med Clin (Barc). 2005 Sep 10;125(8):301-16. doi: 10.1157/13078424. No abstract available. Spanish.
Results Reference
background
PubMed Identifier
16393280
Citation
Guell M, Artigau E, Esteve V, Sanchez-Delgado J, Junquera F, Calvet X. Usefulness of a delayed test for the diagnosis of Helicobacter pylori infection in bleeding peptic ulcer. Aliment Pharmacol Ther. 2006 Jan 1;23(1):53-9. doi: 10.1111/j.1365-2036.2006.02726.x.
Results Reference
background
PubMed Identifier
11121912
Citation
Garcia-Altes A, Jovell AJ, Serra-Prat M, Aymerich M. Management of Helicobacter pylori in duodenal ulcer: a cost-effectiveness analysis. Aliment Pharmacol Ther. 2000 Dec;14(12):1631-8. doi: 10.1046/j.1365-2036.2000.00871.x.
Results Reference
background
PubMed Identifier
9440631
Citation
Sung JJ, Leung WK, Suen R, Leung VK, Chan FK, Ling TK, Lau JY, Lee YT, Ng EK, Cheng AF, Chung SC. One-week antibiotics versus maintenance acid suppression therapy for Helicobacter pylori-associated peptic ulcer bleeding. Dig Dis Sci. 1997 Dec;42(12):2524-8. doi: 10.1023/a:1018816729449.
Results Reference
background
PubMed Identifier
11444470
Citation
Gisbert JP, Gonzalez L, de Pedro A, Valbuena M, Prieto B, Llorca I, Briz R, Khorrami S, Garcia-Gravalos R, Pajares JM. Helicobacter pylori and bleeding duodenal ulcer: prevalence of the infection and role of non-steroidal anti-inflammatory drugs. Scand J Gastroenterol. 2001 Jul;36(7):717-24. doi: 10.1080/003655201300191978.
Results Reference
background
PubMed Identifier
6145023
Citation
Marshall BJ, Warren JR. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet. 1984 Jun 16;1(8390):1311-5. doi: 10.1016/s0140-6736(84)91816-6.
Results Reference
background
PubMed Identifier
11246348
Citation
Pellicano R, Peyre S, Leone N, Repici A, De Angelis C, Rizzi R, Rizzetto M, Ponzetto A. The effect of the eradication of Helicobacter pylori infection on hemorrhage because of duodenal ulcer. J Clin Gastroenterol. 2001 Mar;32(3):222-4. doi: 10.1097/00004836-200103000-00008.
Results Reference
background

Learn more about this trial

Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

We'll reach out to this number within 24 hrs