NCT05297695CompletedPhase 2/3
Helicobacter Pylori Eradication Therapy for Epileptic Children
Effect of Treating Helicobacter Pylori Infection on Seizure Frequency in Children With Drug-Resistant Idiopathic Generalized Epilepsy
Source: ClinicalTrials.gov · Last updated 29 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 126 (actual)
- First submitted
- 17 Mar 2022
- Start date
- 20 Apr 2022
- Primary completion date
- 10 Oct 2023
- Lead sponsor
- Sohag University
- Diseases
- Epilepsy
- NCT number
- NCT05297695
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 126
- From 20 Apr 2022 to the primary completion date, 10 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with antibiotics and/or proton pump inhibitors in the last 2 months.
Other illness
- 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.
Who the study is looking for
- 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).
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sohag University Hospital Coordinator of this site? Confirm its status | Sohag | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.