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

NCT07100743 | Active Not Recruiting

• 2 other identifiers: JEP-2023-151FF- 2023-132
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

drug-resistant epilepsy, quality of life, seizure worry, emotional well-being, probiotic, Malaysia

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  To compare the quality of life score pre- and post-administration of probiotics inter- and intragroup of refractory epilepsy patients

  2 months

Secondary Outcomes (1)

• Seizure Frequency

  2 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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. Patients will be instructed to consume one sachet directly before meal (drink water if needed) twice daily, for two months.

Dietary Supplement: Probiotic Agent

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Probiotic Agent DIETARY_SUPPLEMENT

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

Also known as: Hexbio

Intervention

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with refractory focal epilepsy
• Have at least one self-reported seizure per month
• On two or more ASM
• Aged 18 years and above, who is able to read and write in English and/or Bahasa Malaysia
• Provide informed consent

You may not qualify if:

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• Had status epilepticus in the last 12 months
• Seizures related to alcohol / drug abuse / metabolic cause / infections.
• Gastrointestinal related diseases such as lactose intolerance, coeliac disease
• Renal or hepatic insufficiency (Based on recent six-month blood profile)
• Progressive neurological disease (Alzheimer's disease, Parkinson's Disease, Motor Neuron Disease)
• Pregnancy

Sponsors & Collaborators

• National University of Malaysia: lead
• B-Crobes Laboratory Sdn. Bhd: collaborator

Study Sites (1)

National University of Malaysia

Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants are randomized to receive either HEXBIO MCP Granule probiotic or placebo. Patients will be instructed to consume one sachet directly before meal (drink water if needed) twice daily, for two months. 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.

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: April 3, 2023
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

MY (1)