Probiotic in Treatment of Adult Patients With Drug-resist... | NCT05160350

Studies
Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

NCT05160350

Sponsor

Mazandaran University of Medical Sciences

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

42Actual

Phase

Phase 4

Conditions

Epilepsy
Treatment

Interventions

Probiotic

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2021Actual

Primary Completion Date

Oct 23, 2021Actual

Completion Date

Oct 30, 2021Actual

First Submitted Date

Dec 3, 2021

First Submission Date that Met QC Criteria

Dec 3, 2021

First Posted Date

Dec 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2021

Last Update Posted Date

Jan 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nasim Tabrizi, Associate professor of neurology, Mazandaran University of Medical SciencesPrincipal Investigator

Lead Sponsor

Mazandaran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Active Comparator	Familact 2 plus (Zist takhmir pharmaceutical company, Iran), one capsule per day	Drug: Probiotic
Placebo	Placebo Comparator	Similar capsule in shape and size (Zist takhmir pharmaceutical company, Iran), one capsule per day	Drug: Probiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Drug	Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.	Placebo Probiotic

Measure	Description	Time Frame
Change in seizure frequency		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bu Ali Sina Hospital		Sari	Mazandaran	4815837477	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided