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Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

Sponsor
Mazandaran University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05160350
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
6.3
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of Probiotic Effect on Seizure Frequency of Adult Patients With Drug-resistant Epilepsy; A Randomized Double-blind Parallel Placebo-controlled Clinical Trial
Actual Study Start Date :
Apr 21, 2021
Actual Primary Completion Date :
Oct 23, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Probiotic

Familact 2 plus (Zist takhmir pharmaceutical company, Iran), one capsule per day

Drug: Probiotic
Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.
Other Names:
  • Placebo

    		•
    Placebo Comparator: Placebo

    Similar capsule in shape and size (Zist takhmir pharmaceutical company, Iran), one capsule per day

    Drug: Probiotic
    Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in seizure frequency [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bu Ali Sina Hospital Sari Mazandaran Iran, Islamic Republic of 4815837477

    Sponsors and Collaborators

    • Mazandaran University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nasim Tabrizi, Associate professor of neurology, Mazandaran University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05160350
    Other Study ID Numbers:
    • 6938
    First Posted:
    Dec 16, 2021
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Epilepsy
    Drug Resistant Epilepsy

    Study Results

    No Results Posted as of Jan 11, 2022