Ketogenic Diet for Infantile Spasms

This trial explores whether a ketogenic diet, high in fats and low in carbohydrates and proteins, can help prevent epileptic spasms in infants with genetic seizure disorders. Untreated epileptic spasms can worsen developmental outcomes. The trial targets infants diagnosed with epilepsy before six months of age who exhibit abnormal development or neurological issues, such as vision problems or muscle tone abnormalities. Participants will follow a specific ketogenic diet formula to assess its safety and effectiveness. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new dietary intervention.

You may need to stop taking certain medications like vigabatrin, ACTH, corticosteroids, topiramate, or zonisamide, as they are not allowed in the trial. However, other anti-seizure medications are permitted.

Research has shown that the ketogenic diet is generally safe for children with epilepsy, including those with infantile spasms, a type of seizure. Studies have found that it can greatly reduce seizures and sometimes even stop them completely.

A recent study discovered that the ketogenic diet causes fewer and less severe side effects than ACTH, a common treatment for infantile spasms. This suggests it might be a gentler way to manage seizures.

Unlike traditional treatments for infantile spasms, which often include medications like ACTH or Vigabatrin, the ketogenic diet offers a unique approach by altering the body's metabolism. Researchers are excited about this treatment because it provides a non-pharmacological option, potentially reducing the side effects associated with medications. The diet works by shifting the body's energy source from carbohydrates to fats, which may help control seizures more effectively in some infants. Additionally, it can be administered orally or through a gastrostomy tube, offering flexibility for infants with different feeding needs.

Research has shown that the ketogenic diet, which participants in this trial will receive, can help reduce epileptic spasms in infants. Studies have found that at 3, 6, and 12 months after starting the diet, about 60% or more of infants experienced at least a 50% reduction in spasms. One study discovered that more than half of the infants became seizure-free within two weeks when the ketogenic diet was the first treatment used. This diet, high in fats and low in carbohydrates, has succeeded even when other treatments did not work. Overall, the ketogenic diet is a promising option for managing epileptic spasms, especially in challenging cases.¹²⁵⁶⁷