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Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

Primary Purpose

Epilepsy, Treatment

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Probiotic
Sponsored by
Mazandaran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Bu Ali Sina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in seizure frequency

Secondary Outcome Measures

Full Information

First Posted
December 3, 2021
Last Updated
December 24, 2021
Sponsor
Mazandaran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05160350
Brief Title
Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
October 23, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Familact 2 plus (Zist takhmir pharmaceutical company, Iran), one capsule per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Similar capsule in shape and size (Zist takhmir pharmaceutical company, Iran), one capsule per day
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Placebo
Intervention Description
Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.
Primary Outcome Measure Information:
Title
Change in seizure frequency
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bu Ali Sina Hospital
City
Sari
State/Province
Mazandaran
ZIP/Postal Code
4815837477
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

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