Efficacy of treating Helicobacter pylori infection on seizure frequency in children with drug-resistant idiopathic generalized epilepsy: a randomized controlled trial

TL;DR

Treating Helicobacter pylori infection may reduce seizures in children with drug-resistant epilepsy, according to a clinical trial.

Contribution

This is the first randomized controlled trial to show that eradicating H. pylori can improve seizure control in children with drug-resistant idiopathic generalized epilepsy.

Findings

Seizure improvement was observed in 33% of the treatment group versus 12% in the control group.

The treatment group had fewer cases of status epilepticus and less need for increased antiseizure medication.

Adverse effects were more common in the treatment group but not statistically significant.

Abstract

Helicobacter pylori (H. pylori) causes chronic infection in more than half of the population worldwide. Accumulating body of evidence indicates the possible role of H. Pylori infection in extra-intestinal health problems, including epilepsy. This study aims to investigate the efficacy of treating H. pylori infection on seizure frequency among children with drug-resistant idiopathic generalized epilepsy (IGE).

A parallel, two-arm, open-label, randomized controlled trial was conducted on 126 children with drug-resistant IGE and positive H. pylori stool antigen test who were randomly assigned to study and comparison groups in 1.2:1 ratio. Only the study group received H. pylori eradication therapy (esomeprazole, amoxicillin, and clarithromycin) for two weeks. The primary outcome was seizure improvement (≥ 50% seizure frequency reduction compared with baseline) after 2.5 months. Secondary outcomes were occurrence of status epilepticus, escalation of antiseizure medication (ASMs), and adverse effects. Outcomes between the two groups were compared using Chi-square/Fisher exact tests on an intention-to-treat principle. Logistic regression analysis was performed to investigate possible effects of baseline variables on primary outcome.

Seizure improvement occurred in 23 (33%) children in the study group compared with seven (12%) children in the comparison group (Risk ratio [RR] 2.7, 95% confidence interval [CI]: 1.3–5.9; p 0.006). The study group had lower occurrence of status epilepticus (2.9% vs. 14%; RR 0.21, 95%CI: 0.05–0.93; p 0.042) and lesser need for ASMs escalation (4.4% vs. 19.3%; RR 0.23, 95%CI: 0.07–0.77; p 0.010). Adverse effects were more frequent among subjects in the study group, including nausea (15.9% vs. 10.5%) vomiting (8.7% vs. 3.5%), diarrhea (11.6% vs. 5.3%), and skin rash (4.4% vs. 1.8%), but the differences were not statistically significant (p > 0.05). None of baseline participants’ variables was significantly associated with the primary outcome.

Treating H. pylori infection may improve seizure control in children with drug-resistant IGE, but further studies are warranted to confirm our findings and explore mechanisms behind seizure improvement following H. pylori eradication therapy.

Registered on www.clinicaltrials.gov (identifier: NCT05297695) on 17 March 2022. https://clinicaltrials.gov/study/NCT05297695.

The online version contains supplementary material available at 10.1186/s13052-025-01956-2.

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