Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

Mazandaran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Epilepsy; Treatment

Treatments: Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT05160350

6938

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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

Treatment:

Drug: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Probiotic