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Low-Glycemic Diet for Epilepsy
N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy
Be between 18 and 65 years old
Must not have
Antibiotic use in past 3 months
Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the intervention until 3 months postpartum
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how a low glycemic diet affects pregnant people with epilepsy, examining how it affects their seizures, tolerance, and gut bacteria.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of a low glycemic index diet may include changes in bowel habits, such as constipation or diarrhea, possible nutrient deficiencies if not properly managed, and hypoglycemia (low blood sugar levels).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with epilepsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have taken antibiotics in the last 3 months.
Select...
I have diabetes.
Select...
I have not had any seizures.
Select...
I have a disorder affecting my nervous system's functioning.
Select...
My primary health issue is related to my digestive system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the intervention until 3 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the intervention until 3 months postpartum
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tolerability of the low glycemic index diet in pregnant people with epilepsy
Secondary study objectives
Gut Bacteria Composition
Metabolic pathway alterations
Seizure Frequency
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,843,445 Total Patients Enrolled
11 Trials studying Epilepsy
54,292 Patients Enrolled for Epilepsy
Epilepsy FoundationOTHER
11 Previous Clinical Trials
594 Total Patients Enrolled
9 Trials studying Epilepsy
551 Patients Enrolled for Epilepsy