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Drug Resistant EpilepsyPhase 2NCT05539287

Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy

A Phase 2 study testing Lactobacillus-Based Capsule in people with Drug Resistant Epilepsy, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Drug Resistant Epilepsy
What is being tested?
Lactobacillus-Based Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
25 Sep 2022to 1 Feb 2025
Phase
Phase 2
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 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Amira

    Tanta

Other trials in Egypt

About this study

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.

Read the detailed description

This study will be a placebo-controlled, double-blind, and parallel 6-month duration study

Being tested
Lactobacillus-Based Capsule
Keywords
Lactobacillus
Medical subject headings
Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactobacillus-Based CapsuleDrug

    Also called Lactobacillus

    25 patients will receive Lactobacillus species 5 billion colonies forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.

Study groups in NCT05539287
Study groupRoleWhat they receive
Control groupPlacebo comparator25 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.
Receives: Drug: Lactobacillus-Based Capsule
Probiotic GroupExperimental25 patients will receive Lactobacillus species 5 billion colony forming unit (CFU) 2 capsules daily together with their standard antiepileptic drug for 6 months.
Receives: Drug: Lactobacillus-Based Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy

    effectivness can be defined as more than 50% reduction in number of seizures.

    Measured: 6 months

Secondary outcomes (1)

  1. 1. the change in the concentration of measured biological parameters (NLRP3, and GAD-Ab)

    Before and 6 months after intervention, 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture between 8 am and 11 am. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of :

    • Serum NLRP3 inflammasome level.
    • Serum glutamic acid decarboxylase antibody (GAD-Ab).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start25 Sep 2022
  3. Primary completion5 Aug 2024
  4. Study completion1 Feb 2025

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05539287
Sponsor's protocol ID
Lactobacillus in DRE.
Status last verified
Aug 2023
First submitted
10 Sep 2022
Last updated
1 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rashdan AR, El-Haggar SM, Kishk AM, Mostafa TM. Probiotic Supplementation as an Adjuvant Therapy in Pediatric Drug-Resistant Epilepsy: A Double-Blind Placebo-Controlled Trial. Pharmacotherapy. 2026 Mar;46(3):e70117. doi: 10.1002/phar.70117.

    PubMed 41693686

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lactobacillus-Based Capsule in people with Drug Resistant Epilepsy, run by Tanta 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 3 inclusion and 6 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 1 Jul 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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?

effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy (time frame: 6 months). 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 NCT05539287, which also lists 1 linked publication.

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 1 Jul 2025.

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