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EPIGUT: Epilepsy and Gastrointestinal Microbiota Understanding Therapy Response
Led by Karolinska Institutet · Updated on 2025-11-28
1500
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the link between the bacteria in the gut and mouth (microbiota) and different types of epilepsy, as well as how these bacteria might influence the effectiveness of seizure medicines. This observational study focuses on individuals newly diagnosed with epilepsy who have not yet started treatment, compared with healthy controls. The study aims to understand how microbiota profiles relate to epilepsy subtypes and treatment responses, with the goal of improving seizure control and reducing side effects in the future. Participants will provide biological samples including blood, stool, and saliva, with cerebrospinal fluid samples collected if available from medical procedures. Healthy controls provide stool and saliva samples. Samples will be collected at diagnosis and again at about three months during treatment evaluation. For patients with drug-resistant epilepsy, additional samples and questionnaires will be collected before and after alternative treatments like ketogenic diet, nerve stimulation, or surgery. Throughout the study, participants complete online questionnaires about health and lifestyle. Researchers will analyze microbial composition using advanced sequencing and bioinformatics tools to identify patterns linked to epilepsy types and treatment efficacy. They will also assess inflammation and metabolic profiles in blood and cerebrospinal fluid. Data from medical records on diagnosis, treatment, and seizure burden will be included. The study spans several years, with outcomes measured up to three years after sample collection.
CONDITIONS
Brief Title
EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 2 to 79 years, newly diagnosed with epilepsy, and have not started seizure medication
- Healthy controls aged 2 to 79 years
You will not qualify if you...
- Patients who have started anti-seizure medication (more than one dose)
- Use of antibiotics or probiotics in the last three months
- Diagnosis of gastrointestinal disease
- Surgical removal of parts of the gastrointestinal tract
- Obesity with BMI over 30
- Type 2 diabetes
- Following a strict exclusion diet
- Pregnancy or breastfeeding
- Presence of gastrostomy, PEG, or jejunostomy
- Controls with previous epilepsy diagnosis or anti-seizure medication use
- Controls with any of the above exclusion conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At time of diagnosis
Participants provide baseline saliva, fecal, blood, and cerebrospinal fluid samples if clinically taken, and answer questionnaires to analyze gut and oral microbiota as well as inflammation and metabolism profiles.
1 baseline visit (in-person)
Duration - Up to 3 months after start of therapy
Participants with newly diagnosed epilepsy on anti-seizure medication monotherapy provide follow-up samples and questionnaires to study changes in microbiota, inflammation markers, and metabolites in relation to therapy response.
1 follow-up visit (in-person)
Duration - Varies depending on alternative treatment duration
Participants with drug-resistant epilepsy provide additional samples and questionnaires before and after alternative treatments such as ketogenic diet, vagus nerve stimulation, or surgery to study microbiota and therapy outcomes.
1 to 2 visits depending on treatment
Trial Site Locations
Total: 6 locations
1
Drottning Silvias Barnsjukhus
Gothenburg, Sweden
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2
Universitetssjukhuset i Linköping
Linköping, Sweden
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3
Skånes universitetssjukhus
Lund, Sweden
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4
Karolinska Universitetssjukhus
Stockholm, Sweden
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5
Norrlands universitetssjukhus
Umeå, Sweden
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6
Akademiska Sjukhuset
Uppsala, Sweden
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Research Team
R
Ronny Wickström, MD, PhD
S
Stefanie Prast-Nielsen, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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