Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

Phase 4

Completed

• Conditions: Epilepsy; Treatment
• Interventions: Drug: Probiotic

• Registration Number: NCT05160350
• Lead Sponsor: Mazandaran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-21
• Primary Completion: 2021-10-23
• Study Completion: 2021-10-30
• Status Verified: 2021-12
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-16
• Last Update Submitted: 2021-12-24
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Familact 2 plus (Zist takhmir pharmaceutical company, Iran), one capsule per day
Placebo	Probiotic	Similar capsule in shape and size (Zist takhmir pharmaceutical company, Iran), one capsule per day

Primary Outcome Measures

Name	Time	Method
Change in seizure frequency	12 weeks

Trial Locations

Locations (1)

Bu Ali Sina Hospital; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of