Evaluation of the effect of probiotic supplementation on seizure frequency and quality of life in patients with epilepsy

Investigating the effect of probiotic supplement treatment on seizure frequency and quality of life of patients with epilepsy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251217068369N1

Enrollment

Registered

2025-12-30

Start date

2026-01-25

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy. Epilepsy and recurrent seizures

Interventions

Intervention group: Probiotic recipient.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years. Diagnosis of drug-resistant epilepsy (DRE) confirmed by a specialist. At least two years elapsed since the diagnosis of the first seizure. Current treatment with at least two anti-epileptic drugs (AEDs) from different pharmacological classes. Patients diagnosed with idiopathic epilepsy are also eligible for inclusion.

Exclusion criteria

Exclusion criteria: Non-epileptic seizures. History of status epilepticus within the past 12 months. Any change in the type or dosage of anti-epileptic drug (AED) therapy within 30 days prior to study enrollment. Seizures related to alcohol or substance intoxication/overuse. Pregnancy and/or breastfeeding. Probiotic therapy within 30 days prior to study entry. Presence of chronic gastrointestinal diseases. Hepatic or renal failure. Lactose intolerance. Celiac disease. Depression. Long-term antibiotic use. Any severe psychiatric disorder. Participation in any epilepsy-related clinical study. Life expectancy of less than one year. Psychotic seizures leading to epilepsy. Acute phase of an infectious disease. Significant functional impairment. Psychogenic seizures (PNES).

Design outcomes

Primary

Measure	Time frame
Seizure frequency. Timepoint: Before the intervention (once, at the end of the three-month pre-intervention monitoring period — baseline), immediately after the intervention (at the end of month four of the intervention period), and post-intervention follow-up (four months after discontinuation of the probiotic — month eight from study initiation). Method of measurement: The seizure frequency questionnaire was provided to the participants.;Epilepsy-related quality of life. Timepoint: Before the intervention (once, at the end of the three-month pre-intervention monitoring period — baseline), immediately after the intervention (at the end of month four of the intervention period), and post-intervention follow-up (four months after discontinuation of the probiotic — month eight from study initiation). Method of measurement: The standardized QOLIE-31-P questionnaire (Iranian version).	—

Measure

Time frame

Seizure frequency. Timepoint: Before the intervention (once, at the end of the three-month pre-intervention monitoring period — baseline), immediately after the intervention (at the end of month four of the intervention period), and post-intervention follow-up (four months after discontinuation of the probiotic — month eight from study initiation). Method of measurement: The seizure frequency questionnaire was provided to the participants.;Epilepsy-related quality of life. Timepoint: Before the intervention (once, at the end of the three-month pre-intervention monitoring period — baseline), immediately after the intervention (at the end of month four of the intervention period), and post-intervention follow-up (four months after discontinuation of the probiotic — month eight from study initiation). Method of measurement: The standardized QOLIE-31-P questionnaire (Iranian version).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Khoshkhoy Nilash

Zanjan University of Medical Sciences

shandelfordarkness@gmail.com+98 24 3314 0338

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026