NCT05160350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 3, 2021

Last Update Submit

December 24, 2021

Conditions

EpilepsyTreatment

Outcome Measures

Primary Outcomes (1)

  • Change in seizure frequency

    12 weeks

Study Arms (2)

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

ProbioticDRUG

Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.

Also known as: Placebo
PlaceboProbiotic

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Drug resistant epilepsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bu Ali Sina Hospital

Sari, Mazandaran, 4815837477, Iran

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of neurology

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 16, 2021

Study Start

April 21, 2021

Primary Completion

October 23, 2021

Study Completion

October 30, 2021

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)