EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE

NCT07253701 | Recruiting

• 1 other identifier: 2023-04648-01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this observational study is to learn how the bacteria in the gut and mouth (called the microbiota) are linked to different types of epilepsy and how they may affect how well seizure medicines work. Researchers want to answer two main questions: Are certain types of epilepsy linked to changes in the gut or mouth microbiota? Do the bacteria in the gut change how seizure medicines work for each person? Epilepsy is a brain condition that causes seizures. Even though there are many medicines for epilepsy, some people still have seizures or side effects. Studies in animals show that gut bacteria can raise or lower the chance of seizures. Smaller studies in people suggest the same thing, but they have been limited in size and scope. In this study, researchers will collect biological samples from people who have newly diagnosed epilepsy and from people without epilepsy (called healthy controls). The samples will be tested to learn which bacteria are present. The researchers will then look for patterns that may explain which types of epilepsy are linked to changes in the microbiota. The study will also look at whether the bacteria in the gut and mouth affect how well anti-seizure medicines (ASMs) work. For example, the researchers will explore if certain bacteria make medicines work better or worse. Patients will provide blood, stool and saliva samples. If collected for medical reasons, cerebrospinal fluid (CSF) - the clear liquid that surrounds the brain and spinal cord -will also be used. Healthy controls will provide stool and saliva samples only All participants will be asked to fill an online questionnaire to share health and lifestyle information. Patients also allow researchers to confidentially access data from medical records related to diagnosis and treatment. By comparing data from many participants across Sweden, researchers hope to understand how gut and mouth bacteria influence epilepsy and seizure control. This research may help doctors in the future to use a person's microbiota profile to choose the best seizure medicine. The long-term goal is to improve seizure control, reduce side effects, and raise the quality of life for people living with epilepsy.

Conditions

Epilepsy; Microbiota; Proteomics; Metabolomics; Biomarker Discovery

Keywords

seizures; microbiome; anti-seizure medication; gut-brain-axis; epilepsy

Outcome Measures

Primary Outcomes (2)

• Gut and oral microbiota composition in patients vs. controls

  metagenomic sequencing of home-collected fecal and saliva samples

  two years after completion of sample collection and sequencing

• Changes in gut/oral microbiota in epilepsy patients on monotherapy

  Metagenomic sequencing of at home-collected fecal and saliva samples before and after single ASM treatment for approx. three months

  two years after completion of sample collection and sequencing

Secondary Outcomes (2)

• Changes in inflammation markers and metabolites in blood and CSF during monotherapy and in relation to changes in the microbiota

  three years after completion of sample collection and sequencing

• Can the gut/oral microbiota at time of diagnosis predict therapy response?

  three years after completion of sample collection and sequencing

Other Outcomes (1)

• Changes in the gut/oral microbiota of therapy-resistant epilepsy during alternative treatment

  four years after completion of sample collection and sequencing

Study Arms (2)

Patients

Age 2-79 years, newly diagnosed with epilepsy, treatment-naive at time of enrollment. Exclusion criteria: already started ASM treatment (more then one dose), has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy

Controls

Age 2-79 years, exclusion criteria: previous epilepsy diagnosis or ASM treatment, has used antibiotics or probiotics in the last three months, has a gastrointestinal diagnosis, has surgically removed parts of the GIT, obesity (BMI\>30), T2D, follows a strict exclusion diet, is pregnant or breastfeeding, has a gastrostomy, PEG or jejunostomy

Eligibility Criteria

• Age: 2 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of Sweden

You may qualify if:

• Patients: Age 2-79 years, newly diagnosed with epilepsy, treatment-naive at time of enrollment
• Controls: Age 2-79 years

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (6)

Drottning Silvias Barnsjukhus

Gothenburg, Sweden

RECRUITING

Universitetssjukhuset i Linköping

Linköping, Sweden

RECRUITING

Skånes universitetssjukhus

Lund, Sweden

RECRUITING

Karolinska Universitetssjukhus

Stockholm, Sweden

RECRUITING

Norrlands universitetssjukhus

Umeå, Sweden

RECRUITING

Akademiska Sjukhuset

Uppsala, Sweden

RECRUITING

Related Links

• Karolinska Institutets official site for EpiGUT which includes a link for registration of participation

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples Saliva samples Dried blood spots CSF

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefanie Prast-Nielsen, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Ronny Wickström, MD, PhD

CONTACT

+46 70 68 38 182; ronny.wickstrom@ki.se

Stefanie Prast-Nielsen, PhD

CONTACT

+46 76 21 67 781; stefanie.prast-nielsen@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: February 27, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: At time of publication of research results in a high-quality peer-reviewed scientific journal.
• Access Criteria: Anyone with access to the journal and the ENA (European Nucleotide Archive) portal (storage of sequencing data)

Locations

SE (6)