Last updated: January 25, 2024
Sponsor: Sohag University
Overall Status: Completed
Phase
2/3
Condition
Epilepsy
Seizure Disorders
Treatment
Triple therapy for H. pylori infection
Clinical Study ID
NCT05297695
soh-med-22-03-13
Ages 4-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 generalizedtonic-clonic seizures only (IGE-TCS).
- Drug-resistant epilepsy, defined as failure of adequate trials of two tolerated andappropriately chosen and used anti-epileptic drugs schedules (whether as monotherapiesor in combination) to achieve sustained seizure freedom
- Positive H. pylori stool antigen (HpSA) test (at initial screening).
Exclusion
Exclusion Criteria:
- Failure to obtain informed consent.
- Presence of a medical indication for treating H. pylori infection, including gastricor duodenal ulcer, chronic immune thrombocytopenic purpura, and refractory irondeficiency anemia.
- Known allergy or contraindications to any of the study drugs.
- Treatment with antibiotics and/or proton pump inhibitors in the last 2 months.
Study Design
Total Participants: 126
Treatment Group(s): 1
Primary Treatment: Triple therapy for H. pylori infection
Phase: 2/3
Study Start date:
April 20, 2022
Estimated Completion Date:
December 30, 2023
Study Description
Connect with a study center
Sohag University Hospital
Sohag, 82524
EgyptSite Not Available
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