Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

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.

Completed

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Treatment

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bu Ali Sina Hospital

Sari, Mazandaran, 4815837477, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Drug

Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.

Other names: Placebo

Primary outcomes

Change in seizure frequency

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Dec 16, 2021
Registry last updated: Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed