Helicobacter Pylori Eradication Therapy for Epileptic Children
Condition: Epilepsy, Generalized; Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections; Epilepsy; Epilepsy, Generalized
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Triple therapy for H. pylori infection
Intervention type(s): Drug
Intervention description(s): Triple therapy for H. pylori infection (Esomeprazole, Amoxicillin, and Clarithromycin) for two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; Epilepsy; Helicobacter pylori; Treatment; Seizure