~7 spots leftby Nov 2025

Low-Glycemic Diet for Epilepsy

Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Brigham and Women's Hospital
No Placebo Group
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to learn about the low glycemic index diet in pregnant people with epilepsy. The main questions it aims to answer are: * Is the low glycemic index tolerable in pregnant people with epilepsy? * Does the low glycemic index alter seizure frequency in pregnant people with epilepsy? * Does the low glycemic index alter the gut bacteria \& associated metabolic pathways in pregnant people with epilepsy? Participants will start the low glycemic index diet during pregnancy and will provide stool and blood samples a maximum of 3 times during study duration. Researchers will compare pregnant people with epilepsy on the diet to pregnant people with epilepsy not on a structured diet plan to see if tolerability, seizure frequency, and gut bacteria composition \& metabolites differ.

Eligibility Criteria

This trial is for pregnant individuals with epilepsy. Participants will be following a low glycemic index diet and providing stool and blood samples up to three times during the study. The trial excludes those not willing to adhere to the dietary plan or unable to provide samples as required.

Inclusion Criteria

Pregnant up to 20 weeks gestational age
I have been diagnosed with epilepsy.

Exclusion Criteria

I have diabetes.
I have taken antibiotics in the last 3 months.
I have not had any seizures.
+2 more

Participant Groups

Researchers are testing if a low glycemic index diet is tolerable, can change seizure frequency, and affect gut bacteria in pregnant people with epilepsy. They'll compare results from participants on this diet against those who aren't following any structured diet plan.
2Treatment groups
Experimental Treatment
Active Control
Group I: Low Glycemic Index Diet GroupExperimental Treatment1 Intervention
A low glycemic index diet will be started with ongoing dietician support \& food questionnaires until pregnancy completion.
Group II: Standard Diet GroupActive Control1 Intervention
A standard diet, as chosen by participants, will be followed with ongoing food questionnaires until pregnancy completion.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?

Brigham and Women's HospitalLead Sponsor
Epilepsy FoundationCollaborator

References