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Helicobacter Pylori Eradication Therapy for Epileptic Children

Primary Purpose

Epilepsy, Generalized, Helicobacter Pylori Infection

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Triple therapy for H. pylori infection

About this trial

This is an interventional treatment trial for Epilepsy, Generalized focused on measuring Children, Epilepsy, Helicobacter pylori, Treatment, Seizure

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.
Positive H. pylori stool antigen test 1 month after treatment in the study group (treatment failure).
Treatment with antibiotics and/or proton pump inhibitors in the control group.

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Seizure frequency

Secondary Outcome Measures

Number of antiepileptic drugs

Dose of antiepileptic drugs

Number of generalized convulsive status epilepticus

Frequency of adverse effects of H. pylori eradication therapy

Full Information

NCT ID

NCT05297695

First Posted

March 17, 2022

Last Updated

July 2, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05297695

Brief Title

Helicobacter Pylori Eradication Therapy for Epileptic Children

Official Title

Effect of Treating Helicobacter Pylori Infection on Seizure Frequency in Children With Drug-Resistant Idiopathic Generalized Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

August 20, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Helicobacter pylori (H. pylori) is a spiral-shaped Gram-negative bacterium, which causes chronic infection in more than 50% of human population. H. pylori infection is associated with several gastrointestinal disorders, such as gastritis and gastric/duodenal ulcers. Moreover, accumulating body of evidence indicates the possible role of H. Pylori infection in extraintestinal health problems, such as iron deficiency anemia, immune thrombocytopenic purpura (ITP), numerous dermatological diseases, Alzheimer disease, Parkinson's disease, multiple sclerosis, and epilepsy. Epilepsy is a common neurological disorder characterized by recurrent unprovoked seizures. This condition affects 0.5% to 1% of all children and is associated with neurobiological, cognitive, psychological, and social consequences. Seizures can usually be controlled by anti-epileptic drugs (AEDs) in up to two-thirds of children with epilepsy. However, this leaves a significant part of epileptic children whose seizures are not controlled by pharmacotherapy. The development of epilepsy is highly complex and can be attributed to multiple etiologies classified into structural (e.g., malformation, trauma, ischemia), genetic, infectious, metabolic, and immune factors. However, the etiology remains unknown in about half of epileptic children. Idiopathic generalized epilepsies (IGE) constitute about one-third of all epilepsies. Efforts to explore new possible mechanisms contributing to the development of epilepsy, particularly drug-resistant IGE, could contribute to the development of new therapeutic strategies to improve patients' outcomes. The role of H. pylori infection in epilepsy has been investigated in a few studies, some of which reported that the seroprevalence of H. pylori infection is significantly higher in patients with idiopathic epilepsy compared with patients with other chronic diseases, and that H. pylori infection is associated with poor prognosis. Potential H. pylori-induced epileptic effects are probably immune-mediated that can be attributed to a cross-mimicry mechanism between H. pylori and human cellular phospholipids with production of autoimmune antibodies (e.g., anti-cardiolipin) and H. pylori infection-related activation of pro-inflammatory cells with systemic release of proinflammatory cytokines (e.g., IL-6, 8 and TNF- α) which are involved in disruption of the blood-brain barrier and neuroinflammation. 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 IGE. This study aims to evaluate the effect of treating H. pylori infection on seizure frequency among children with drug-resistant IGE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Generalized, Helicobacter Pylori Infection

Keywords

Children, Epilepsy, Helicobacter pylori, Treatment, Seizure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Triple therapy for H. pylori infection

Intervention Description

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

Primary Outcome Measure Information:

Title

Seizure frequency

Time Frame