EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 79
Healthy Volunteers: t
View:

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

• Controls: Age 2-79 years

Locations
Other Locations
Sweden
Drottning Silvias Barnsjukhus
RECRUITING
Gothenburg
Universitetssjukhuset i Linköping
RECRUITING
Linköping
Skånes universitetssjukhus
RECRUITING
Lund
Karolinska Universitetssjukhus
RECRUITING
Stockholm
Norrlands universitetssjukhus
RECRUITING
Umeå
Akademiska Sjukhuset
RECRUITING
Uppsala
Contact Information
Primary
Ronny Wickström, MD, PhD
ronny.wickstrom@ki.se
+46 70 68 38 182
Backup
Stefanie Prast-Nielsen, PhD
stefanie.prast-nielsen@ki.se
+46 76 21 67 781
Time Frame
Start Date: 2024-02-27
Estimated Completion Date: 2028-03
Participants
Target number of participants: 1500
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov