Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

Investigation of Probiotic Effect on Seizure Frequency of Adult Patients With Drug-resistant Epilepsy; A Randomized Double-blind Parallel Placebo-controlled Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05160350

Enrollment

Registered

2021-12-16

Start date

2021-04-21

Completion date

2021-10-30

Last updated

2022-01-11

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

Conditions

Epilepsy, Treatment

Brief summary

This study is a randomized, double-blind parallel group placebo-controlled clinical trial with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult patients with epilepsy.

Interventions

DRUGProbiotic

Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

Healthy volunteers

Inclusion criteria

Drug resistant epilepsy

Exclusion criteria

* Hypersensitivity to probiotic * Acute pancreatitis * Pregnancy * Breastfeeding * Being under treatment with corticosteroids * Being under treatment with antibiotics during 2 months before enrollment * Need for antibiotic therapy during the study * Change in anti-seizure medication within the month before enrollment

Design outcomes

Primary

Measure	Time frame
Change in seizure frequency	12 weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026