Status:
COMPLETED
Helicobacter Pylori Eradication Therapy for Epileptic Children
Lead Sponsor:
Sohag University
Conditions:
Epilepsy, Generalized
Helicobacter Pylori Infection
Eligibility:
All Genders
4-18 years
Phase:
PHASE2
PHASE3
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, ...
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 gastroin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05297695
Start Date
April 20 2022
End Date
December 30 2023
Last Update
January 29 2024
Active Locations (1)
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1
Sohag University Hospital
Sohag, Egypt, 82524