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CompletedNCT05160350Updated Jan 11, 2022

Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

A Phase 4 interventional study of Probiotic in Epilepsy and Treatment, sponsored by Mazandaran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Mazandaran University of Medical Sciences · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2021, registered Dec 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy
  • Treatment
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 42 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Mazandaran University of Medical Sciences is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Drug resistant epilepsy

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Probiotic

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

    Drug: Probiotic

  • Placebo comparator
    Placebo

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

    Drug: Probiotic

Interventions

  • DrugProbiotic

    Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Change in seizure frequency

    Time frame: 12 weeks

07

Study locations

1 site
  • Bu Ali Sina Hospital
    Sari, Mazandaran 4815837477, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05160350
Lead sponsor
Mazandaran University of Medical Sciences
Responsible party
Nasim Tabrizi (Associate professor of neurology, Mazandaran University of Medical Sciences) — Principal investigator
First posted
Dec 16, 2021
Start date
Apr 21, 2021
Primary completion
Oct 23, 2021
Completion
Oct 30, 2021
Last update
Jan 11, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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