Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

NCT ID: NCT05160350

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2021-10-30

Brief Summary

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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

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Conditions

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Epilepsy Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Probiotic

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

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DRUG

Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.

Placebo

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

Group Type PLACEBO_COMPARATOR

Probiotic

Intervention Type DRUG

Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.

Interventions

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Probiotic

Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mazandaran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nasim Tabrizi

Associate professor of neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bu Ali Sina Hospital

Sari, Mazandaran, Iran

Site Status

Countries

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Iran

Other Identifiers

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6938

Identifier Type: -

Identifier Source: org_study_id

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