Helicobacter Pylori Eradication Therapy for Epileptic Children (NCT05297695) | Clinical Trial Compass
CompletedPhase 2/3
Helicobacter Pylori Eradication Therapy for Epileptic Children
Egypt126 participantsStarted 2022-04-20
Plain-language 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.
Who can participate
Age range
4 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Treatment with antibiotics and/or proton pump inhibitors in the last 2 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seizure improvement
Timeframe: 2.5 months following H. pylori eradication therapy