NCT02410902

A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)

A Double Blind, Randomized, Placebo-Controlled Study of CM-AT for the Treatment of Autism in Children With All Levels of Fecal Chymotrypsin (FCT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Curemark · Industry
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.

Detailed description

Autism is clearly a significant cause of disability in the pediatric population. Many children with Autism exhibit impaired protein digestion which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.

Conditions

• Autism

Interventions

Type	Name	Description
DRUG	CM-AT	Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
DRUG	PLACEBO	Single unit dose powder of non-active substance administered 3 times per day for 90 days

Timeline

• Start date: 2015-05-13
• Primary completion: 2017-12-22
• Completion: 2017-12-22
• First posted: 2015-04-08
• Last updated: 2023-05-24
• Results posted: 2022-10-26

Locations

31 sites across 1 country: United States