Trial of Multi-Strain Probiotic Supplementation (Hexbio®) in Malaysian Patients With Drug-Resistant Epilepsy (ProbE)

Summary

Probiotics are good, live bacteria and/or yeast, that live in our guts and causes no harm. They help in digestion and overall well-being of our gut system. The purpose of the study is to assess the effect of probiotics on the quality of life and seizure frequency in epilepsy patients with uncontrolled seizures.

This experimental study involves an interview by the researchers from UKM for the demographic of epilepsy, seizure control and quality of life using a questionnaire. The questionnaire will take about 15 minutes to complete, and you will need to answer all questions without assistance.

You will be randomized either into the active group or the placebo group. If you are in the active group, you will need to take one HEXBIO MCP Granule probiotics sachet directly before meal (drink water if needed) twice daily, for two months, in addition to your pre-existing epilepsy treatment. The HEXBIO MCP Granule probiotic consists of the following probiotics: Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium infantis and Bifidobacterium longum. Initially, some people may experience temporary mild gastrointestinal symptoms such as abdominal cramping, soft stools and flatulence as body adapts to the introduction of friendly bacteria. The symptoms will subside gradually after few days.

If you are in the placebo group, you will also need to take one sachet twice daily before meal, for two months, in addition to the epilepsy treatment. The placebo sachets will contain the same ingredient as the probiotic sachet but without the Lactobacillus sp. and Bifidobacterium sp. The placebo sachet is also to be taken the same way as the probiotic sachet.

At two months of follow up, you will be interviewed once again to assess the changes of seizure frequency (using seizure diary), quality of life and the adverse effects of experienced. A sachet-count (using sachet diary) will also be done to assess the compliance.

Benefits This study is done in an attempt to assess the changes in quality of life and seizure frequency in patients with refractory epilepsy as compared to the control group.

Risks There is no risk in this study. All information disclosed during this study is strictly confidential. You do not have to pay to participate in this study.

If seizure or quality of life worsened during this period, you will be referred to the respective team for the optimization of anti-seizure medications.

Do you have to take part? Participation in this study is voluntary. If you agree to take part, then you will be asked to sign the "informed Consent Form". Should you decide to participate, you can still withdraw at any time during the study without penalty. Your data will be discarded and not be used. Regardless of your decision at any point in time, your treatment will not be affected.

Data and Confidentiality The data in this study will be made into a report which may be published. The data will be reported in a collective manner with no reference to an individual. Hence your identity will be kept confidential. There is no conflict of interest among the researchers.

Conditions

• Epilepsies Refractory

Interventions

DIETARY_SUPPLEMENT

Probiotic Agent

HEXBIO MCP Granule probiotic is prepared in sachets which consist of the following probiotics: Lactobacillus acidophilus (BCMC 1 12130)107mg, Lactobacillus casei (BCMC 1 12313) -107mg, Lactobacillus lactis (BCMC 1 12451)-107 mg, (BCMC 1 02290) -107mg, Bifidobacterium infantis (BCMC 1 02129) -107mg and Bifidobacterium longum (BCMC 102120)-107mg

DIETARY_SUPPLEMENT

Placebo

The placebo sachets will contain the same ingredient as the probiotic sachet but without the Lactobacillus sp. and Bifidobacterium sp. Participants in the placebo group will receive an identical Hexbio sachet (aluminum foil sachet.) with non-microbial material.

Sponsors & Collaborators

• B-Crobes Laboratory Sdn. Bhd

  collaborator UNKNOWN

• National University of Malaysia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-03

Primary Completion

2026-03-02

Completion

2026-03-02

Countries

• Malaysia

Study Locations