NCT05539287CompletedPhase 2
Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
Animal and human studies have brought up evidence supporting Gut microbial disbalance, namely dysbiosis, as a causative factor of epilepsy, especially the refractory form. thus, probiotics might constitute a safe, low-cost, and effective supplementary therapy in patients with DRE. The Lactobacillus population is probiotic bacteria that have a beneficial role in epilepsy. Lactobacillus can influence brain function through the modulation of GABA, as shown in rodent models. Moreover, it has been demonstrated in animal models of epilepsy and in human epileptic patients that probiotic treatment aimed at restoring gut microbiota equilibrium has beneficial effects on epileptic symptoms by increasing GABA in animals and the levels of Bifidobacteria and Lactobacillus in humans.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 10 Sept 2022
- Start date
- 25 Sept 2022
- Primary completion date
- 5 Aug 2024
- Lead sponsor
- Tanta University
- Diseases
- Epilepsy
- NCT number
- NCT05539287
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 25 Sept 2022 to the primary completion date, 5 Aug 2024
- 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.
Lab values
- Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR \< 60 mL/min/1.73 m2 or electrolyte imbalance.
- Patients who are currently using or used antibiotics therapy in the preceding month
- Patients who are currently using or used other probiotic products in the preceding two weeks
- Patients scheduled to undergo GIT surgery or those who underwent GIT surgery
- Patients with a Known allergy to probiotics.
- Patients receiving artificial enteral or intravenous nutrition
Who the study is looking for
- Patients aged 3-18 years with intractable childhood-onset epilepsy.
- All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.
- The subject is willing and able to comply with the study requirements
Age in the registry: 3 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 |
|---|---|---|---|
| Amira Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
Related publications
- Probiotic Supplementation as an Adjuvant Therapy in Pediatric Drug-Resistant Epilepsy: A Double-Blind Placebo-Controlled Trial.Pharmacotherapy · 2026 · PMID 41693686
This page is information, not medical advice. Discuss any trial with your doctor.