Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Helicobacter Pylori Infection Clinical Trial

— THD-HP  

Official title:

Comparison Between Tailored Therapy Guided by a Non-invasive Antibiotic Susceptibility Test and Empiric Treatment for First-line Helicobacter Pylori Eradication in Patients With Dyspepsia: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107194
• Other study ID #: Policlinic Hospital 6, Bari
• Status: Recruiting
• Phase: Phase 3
• Start date: January 14, 2020
• Est. completion date: April 14, 2022

Study information

• Verified date: January 2021
• Source: University of Bari
• Contact: Michele Barone, Prof.
• Phone: +39 3477157666
• Email: michele.barone[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

Description:

Study design:

Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 362
• Est. completion date: April 14, 2022
• Est. primary completion date: February 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• presence of dyspeptic symptoms, according to Rome IV criteria;

• Helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology);

• naive to Helicobacter pylori treatment;

• written informed consent.

Exclusion Criteria:

• previous Helicobacter pylori treatment;

• diagnosis of gastric cancer or other diseases requiring surgery;

• contraindications to upper endoscopy;

• chronic diarrhea;

• known allergy to any drugs used in the intervention and control arm.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Antibiotic Resistant Strain
• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Pantoprazole 40mg
Proton pump inhibitor
• Amoxicillin 1000 MG
Antibiotic
• Clarithromycin 500mg
Antibiotic
• Metronidazole
Antibiotic
• Tetracycline 125 MG
Antibiotic
• Bismuth Subcitrate
Antibiotic adjuvant
• Rifabutin 150 MG
Antibiotic
• Levofloxacin 500mg
Antibiotic

Locations

Country	Name	City	State
Italy	Michele Barone	Bari	BA

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

References & Publications (5)

De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C, Ierardi E, Zullo A. Worldwide H. pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010 Dec;19(4):409-14. Review. — View Citation

Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19. pii: S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. [Epub ahead of print] — View Citation

Giorgio F, Ierardi E, Sorrentino C, Principi M, Barone M, Losurdo G, Iannone A, Giangaspero A, Monno R, Di Leo A. Helicobacter pylori DNA isolation in the stool: an essential pre-requisite for bacterial noninvasive molecular analysis. Scand J Gastroentero — View Citation

Iannone A, Giorgio F, Russo F, Riezzo G, Girardi B, Pricci M, Palmer SC, Barone M, Principi M, Strippoli GF, Di Leo A, Ierardi E. New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study. World J Gastroenterol. 2018 Jul 2 — View Citation

Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic accuracy parameters	Sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratio, and accuracy of the RT-PCR on fecal samples for the detection of antibiotic resistances	30 days
Primary	Eradication rate	Number of participants achieving Helicobacter pylori eradication	30 days
Secondary	Adverse events	Any adverse event occurring during the 10-day treatment	10 days
Secondary	Participants' compliance	Number of assumed tablets divided by the total number of prescribed tablets	10 days
Secondary	Treatment withdrawal	Withdrawal of any drug included in the prescribed regimen	10 days