NCT05297695

Brief Summary

Helicobacter pylori (H. pylori) infection is associated with several health problems. The role of H. pylori infection in epilepsy has been investigated in a few studies. To the best of our knowledge, there have been no previous studies on the effect of treating H. pylori infection on seizure frequency among children with drug-resistant idiopathic generalized epilepsy. This study aims to evaluate the effect of treating H. pylori infection on seizure frequency among children with drug-resistant idiopathic generalized epilepsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

March 17, 2022

Last Update Submit

January 25, 2024

Conditions

Epilepsy, GeneralizedHelicobacter Pylori Infection

Keywords

ChildrenEpilepsyHelicobacter pyloriTreatmentSeizure

Outcome Measures

Primary Outcomes (1)

  • Seizure improvement

    ≥ 50% seizure frequency reduction compared with baseline

    2.5 months following H. pylori eradication therapy

Secondary Outcomes (3)

  • Need for escalation of antiepileptic drugs

    2.5 months following H. pylori eradication therapy

  • Occurrence of status epilepticus

    2.5 months following H. pylori eradication therapy

  • Occurrence of adverse effects of H. pylori eradication therapy

    2.5 months following H. pylori eradication therapy

Study Arms (2)

Study group

EXPERIMENTAL

Children with drug-resistant idiopathic generalized epilepsy and positive H. pylori stool antigen test who will receive H. pylori eradication therapy.

Drug: Triple therapy for H. pylori infection

Control group

NO INTERVENTION

Children with drug-resistant idiopathic generalized epilepsy and positive H. pylori stool antigen test who will not receive H. pylori eradication therapy.

Interventions

Triple therapy for H. pylori infectionDRUG

Triple therapy for H. pylori infection (Esomeprazole, Amoxicillin, and Clarithromycin) for two weeks

Study group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 4 and 18 years.
  • Idiopathic generalized epilepsies (IGE), including childhood absence epilepsy, juvenile absence epilepsy, juvenile myoclonic epilepsy, or IGE with generalized tonic-clonic seizures only (IGE-TCS).
  • Drug-resistant epilepsy, defined as failure of adequate trials of two tolerated and appropriately chosen and used anti-epileptic drugs schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom
  • Positive H. pylori stool antigen (HpSA) test (at initial screening).

You may not qualify if:

  • Failure to obtain informed consent.
  • Presence of a medical indication for treating H. pylori infection, including gastric or duodenal ulcer, chronic immune thrombocytopenic purpura, and refractory iron deficiency anemia.
  • Known allergy or contraindications to any of the study drugs.
  • Treatment with antibiotics and/or proton pump inhibitors in the last 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, 82524, Egypt

Location

Related Publications (9)

  • Korotkaya Y, Shores D. Helicobacter pylori in Pediatric Patients. Pediatr Rev. 2020 Nov;41(11):585-592. doi: 10.1542/pir.2019-0048.

    PMID: 33139411BACKGROUND

  • Fine A, Wirrell EC. Seizures in Children. Pediatr Rev. 2020 Jul;41(7):321-347. doi: 10.1542/pir.2019-0134.

    PMID: 32611798BACKGROUND

  • Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.

    PMID: 28276062BACKGROUND

  • Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.

    PMID: 24730690BACKGROUND

  • Yao G, Wang P, Luo XD, Yu TM, Harris RA, Zhang XM. Meta-analysis of association between Helicobacter pylori infection and multiple sclerosis. Neurosci Lett. 2016 May 4;620:1-7. doi: 10.1016/j.neulet.2016.03.037. Epub 2016 Mar 23.

    PMID: 27033666BACKGROUND

  • Okuda M, Miyashiro E, Nakazawa T, Minami K, Koike M. Helicobacter pylori infection and idiopathic epilepsy. Am J Med. 2004 Feb 1;116(3):209-10. doi: 10.1016/j.amjmed.2003.05.005. No abstract available.

    PMID: 14749171BACKGROUND

  • Ozturk A, Ozturk CE, Ozdemirli B, Yucel M, Bahcebasi T. Helicobacter pylori infection in epileptic patients. Seizure. 2007 Mar;16(2):147-52. doi: 10.1016/j.seizure.2006.10.015. Epub 2006 Nov 27.

    PMID: 17126040BACKGROUND

  • Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.

    PMID: 19889013BACKGROUND

  • Mohamed MA, Mahmoud EA, Basily MS, Mohamed MM, Ahmed OAA, Abdelkreem E. Efficacy of treating Helicobacter pylori infection on seizure frequency in children with drug-resistant idiopathic generalized epilepsy: a randomized controlled trial. Ital J Pediatr. 2025 Apr 17;51(1):121. doi: 10.1186/s13052-025-01956-2.

    PMID: 40247384DERIVED

MeSH Terms

Conditions

Epilepsy, GeneralizedEpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Montaser M Mohamed, MD, PhD

    Sohag University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

April 20, 2022

Primary Completion

October 10, 2023

Study Completion

December 30, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the study
Access Criteria
Data will be available for researchers upon reasonable request

Locations

EG(1)