Epilepsy, GeneralizedPhase 2/3NCT05297695
Helicobacter Pylori Eradication Therapy for Epileptic Children
A Phase 2/3 study testing Triple therapy for H. pylori infection in people with Epilepsy, Generalized and Helicobacter Pylori Infection, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Epilepsy, Generalized, Helicobacter Pylori Infection
- What is being tested?
- Triple therapy for H. pylori infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 30 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Treating Helicobacter Pylori Infection on Seizure Frequency in Children With Drug-Resistant Idiopathic Generalized Epilepsy
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.
Read the 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.
- Being tested
- Triple therapy for H. pylori infection
- Keywords
- Children, Epilepsy, Helicobacter pylori, Treatment, Seizure
- Medical subject headings
- Epilepsy, Generalized, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple therapy for H. pylori infectionDrug
Triple therapy for H. pylori infection (Esomeprazole, Amoxicillin, and Clarithromycin) for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Children with drug-resistant idiopathic generalized epilepsy and positive H. pylori stool antigen test who will receive H. pylori eradication therapy. Receives: Drug: Triple therapy for H. pylori infection |
| Control group | No intervention | Children with drug-resistant idiopathic generalized epilepsy and positive H. pylori stool antigen test who will not receive H. pylori eradication therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure improvement
≥ 50% seizure frequency reduction compared with baseline
Measured: 2.5 months following H. pylori eradication therapy
Secondary outcomes (3)
Need for escalation of antiepileptic drugs
Need for escalation of antiepileptic drugs compared with baseline
Measured: 2.5 months following H. pylori eradication therapy
Occurrence of status epilepticus
Measured: 2.5 months following H. pylori eradication therapy
Occurrence of adverse effects of H. pylori eradication therapy
Measured: 2.5 months following H. pylori eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start20 Apr 2022
- Primary completion10 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Samy Basily, Sohag University
- Investigators
- Montaser M Mohamed, MD, PhD, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297695
- Sponsor's protocol ID
- soh-med-22-03-13
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Korotkaya Y, Shores D. Helicobacter pylori in Pediatric Patients. Pediatr Rev. 2020 Nov;41(11):585-592. doi: 10.1542/pir.2019-0048.
PubMed 33139411Fine A, Wirrell EC. Seizures in Children. Pediatr Rev. 2020 Jul;41(7):321-347. doi: 10.1542/pir.2019-0134.
PubMed 32611798Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
PubMed 28276062Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
PubMed 24730690Yao G, Wang P, Luo XD, Yu TM, Harris RA, Zhang XM. Meta-analysis of association between Helicobacter pylori infection and multiple sclerosis. Neurosci Lett. 2016 May 4;620:1-7. doi: 10.1016/j.neulet.2016.03.037. Epub 2016 Mar 23.
PubMed 27033666Okuda M, Miyashiro E, Nakazawa T, Minami K, Koike M. Helicobacter pylori infection and idiopathic epilepsy. Am J Med. 2004 Feb 1;116(3):209-10. doi: 10.1016/j.amjmed.2003.05.005. No abstract available.
PubMed 14749171Ozturk A, Ozturk CE, Ozdemirli B, Yucel M, Bahcebasi T. Helicobacter pylori infection in epileptic patients. Seizure. 2007 Mar;16(2):147-52. doi: 10.1016/j.seizure.2006.10.015. Epub 2006 Nov 27.
PubMed 17126040Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
PubMed 19889013Mohamed MA, Mahmoud EA, Basily MS, Mohamed MM, Ahmed OAA, Abdelkreem E. Efficacy of treating Helicobacter pylori infection on seizure frequency in children with drug-resistant idiopathic generalized epilepsy: a randomized controlled trial. Ital J Pediatr. 2025 Apr 17;51(1):121. doi: 10.1186/s13052-025-01956-2.
PubMed 40247384
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treating Helicobacter Pylori Infection on Seizure Frequency in Children With Drug-Resistant Idiopathic Generalized Epilepsy
- ClinicalTrials.gov ID
- NCT05297695
- Acronym / sponsor ID
- soh-med-22-03-13
- Keywords
- Children, Epilepsy, Helicobacter pylori, Treatment, Seizure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Triple therapy for H. pylori infectionChildren with drug-resistant idiopathic generalized epilepsy and positive H. pylori stool antigen test who will receive H. pylori eradication therapy. |
| Control group | No intervention | –Children with drug-resistant idiopathic generalized epilepsy and positive H. pylori stool antigen test who will not receive H. pylori eradication therapy. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple therapy for H. pylori infectionTriple therapy for H. pylori infection (Esomeprazole, Amoxicillin, and Clarithromycin) for two weeks | Drug | Study group |
Primary outcome
Seizure improvement
Time frame: 2.5 months following H. pylori eradication therapy
≥ 50% seizure frequency reduction compared with baseline
3 secondary outcomes
Need for escalation of antiepileptic drugs
Time frame: 2.5 months following H. pylori eradication therapy
Occurrence of status epilepticus
Time frame: 2.5 months following H. pylori eradication therapy
Occurrence of adverse effects of H. pylori eradication therapy
Time frame: 2.5 months following H. pylori eradication therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 33139411Korotkaya Y, Shores D. Helicobacter pylori in Pediatric Patients. Pediatr Rev. 2020 Nov;41(11):585-592. doi: 10.1542/pir.2019-0048.
- Background: PubMed 32611798Fine A, Wirrell EC. Seizures in Children. Pediatr Rev. 2020 Jul;41(7):321-347. doi: 10.1542/pir.2019-0134.
- Background: PubMed 28276062Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
- Background: PubMed 24730690Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
- Background: PubMed 27033666Yao G, Wang P, Luo XD, Yu TM, Harris RA, Zhang XM. Meta-analysis of association between Helicobacter pylori infection and multiple sclerosis. Neurosci Lett. 2016 May 4;620:1-7. doi: 10.1016/j.neulet.2016.03.037. Epub 2016 Mar 23.
- Background: PubMed 14749171Okuda M, Miyashiro E, Nakazawa T, Minami K, Koike M. Helicobacter pylori infection and idiopathic epilepsy. Am J Med. 2004 Feb 1;116(3):209-10. doi: 10.1016/j.amjmed.2003.05.005. No abstract available.
- Background: PubMed 17126040Ozturk A, Ozturk CE, Ozdemirli B, Yucel M, Bahcebasi T. Helicobacter pylori infection in epileptic patients. Seizure. 2007 Mar;16(2):147-52. doi: 10.1016/j.seizure.2006.10.015. Epub 2006 Nov 27.
- Background: PubMed 19889013Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
- Derived from this study: PubMed 40247384Mohamed MA, Mahmoud EA, Basily MS, Mohamed MM, Ahmed OAA, Abdelkreem E. Efficacy of treating Helicobacter pylori infection on seizure frequency in children with drug-resistant idiopathic generalized epilepsy: a randomized controlled trial. Ital J Pediatr. 2025 Apr 17;51(1):121. doi: 10.1186/s13052-025-01956-2.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montaser M Mohamed, MD, PhD study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triple therapy for H. pylori infection in people with Epilepsy, Generalized and Helicobacter Pylori Infection, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure improvement (time frame: 2.5 months following H. pylori eradication therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297695, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.