Bismuth Quadruple Therapy Versus Standard Triple Therapy

NCT06143124 | Unknown Phase 4

• 1 other identifier: BismoHelP
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the standard triple therapy with Bismuth quadruple therapy in children infected with Helicobacter pylori. The main questions to answer are:

• the safety
• the efficacy of the quadruple protocol with Bismuth subcitrate Participants will be randomised in 7-days eradication therapy group and 14-days eradication control group.

Conditions

Helicobacter Pylori Infection

Keywords

children; eradication therapy; antibiotics

Outcome Measures

Primary Outcomes (1)

• Adverse effects of the Bismuth

  questionnaire for possible side effects

  duration of treatment (7 days)

Secondary Outcomes (1)

• Eradication therapy success of 7 days treatment protocol

  one months

Study Arms (2)

Therapeutic arm

ACTIVE COMPARATOR

Classical triple therapy according to the antibiotic susceptibility testing (two antibiotics+PPI)+ Bismuth subcitrate for 7 days

Drug: Bismuth Subcitrate

Control arm

NO INTERVENTION

Classical triple therapy according to the antibiotic susceptibility testing (two antibiotics+PPI) for 14 days

Interventions

Bismuth Subcitrate DRUG

shorter duration of therapy (7 instead of classical 14 days) with four dugs instead of three (adding Bismuth subcitrate).

Therapeutic arm

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female patients
• Age between 5 - 18 years with a
• Minimum body weight of 15 kg
• Endoscopy performed with biopsies taken for culture, histology
• No previous therapy for H. pylori infection
• Written informed consent
• H. pylori infection confirmed by positive culture and with susceptibility testing for clarithromycin and metronidazole to allow tailored therapy

You may not qualify if:

• Significant acute or chronic gastrointestinal disease (IBD, coeliac disease, GERD etc.) or other organic disease interfering with symptom assessment
• Patients with ulcers and need to be treated with PPI according to the physician judgment.
• Known allergies to used antibiotics, proton pump inhibitors or probiotics
• Having received treatment with antibiotics or bismuth compounds during the previous 30 days before endoscopy.
• Having received proton pump inhibitors during the previous two weeks.
• Severe acquired or primary immunodeficiency disorder
• Language barriers which do not allow to give informed consent and/or to adequately complete the study diary
• Being infected with a strain resistant to clarithromycin and metronidazole (double resistant)

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Matjaž Homan

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (3)

• Homan M, Hojsak I, Kolacek S. Helicobacter pylori in pediatrics. Helicobacter. 2012 Sep;17 Suppl 1:43-8. doi: 10.1111/j.1523-5378.2012.00982.x.

  PMID: 22958155 RESULT

• Jones NL, Koletzko S, Goodman K, Bontems P, Cadranel S, Casswall T, Czinn S, Gold BD, Guarner J, Elitsur Y, Homan M, Kalach N, Kori M, Madrazo A, Megraud F, Papadopoulou A, Rowland M; ESPGHAN, NASPGHAN. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016). J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):991-1003. doi: 10.1097/MPG.0000000000001594.

  PMID: 28541262 RESULT

• Butenko T, Jeverica S, Orel R, Homan M. Antibacterial resistance and the success of tailored triple therapy in Helicobacter pylori strains isolated from Slovenian children. Helicobacter. 2017 Oct;22(5):e12400. doi: 10.1111/hel.12400. Epub 2017 Jun 27.

  PMID: 28653787 RESULT

MeSH Terms

Interventions

bismuth tripotassium dicitrate

Central Study Contacts

Matjaž Homan, MD PhD

CONTACT

0038640885848; matjaz.homan@guest.arnes.si

Anja Praprotnik Novak, MD

CONTACT

0038615229276; anja.praprotnik.novak@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: one group (control) the classical eradication treatment therapy (14 days), second group (therapeutic) shorter duration of therapy (7 days) with the same drugs including Bismuth

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 22, 2023
• Study Start: March 3, 2022
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

SL (1)