Clinical Trial: Blüm Investigates Biologic, CM-AT, for Autism

Protein digestion is impaired in many children with autism, which may lead children to restrict their diet. Their inability to digest protein affects the availability of essential amino acids in the body, which play a critical role in expressing several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine.

Cleveland Clinic Children’s is one of 29 sites nationally studying whether a biologic, CM-AT, (Curemark) may improve symptoms of autism in children ages 3 to 8, with all levels of fecal chymotrypsin.

Study design:

The blüm (a study of a BioLogic aUtism Medication) randomized, double-blind Phase III clinical trial is examining CM-AT, which is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids.

Participants will be administered the proprietary enzyme that is designed as a granulated powder in their food three times daily for 90 days.

Outcome measures:

The primary outcome measures are changes in the Aberrant Behavior Checklist subscale for Irritability/Agitation at nine visits between baseline and Week 12. Secondary outcomes measures include changes on the subscale for Lethargy/Social Withdrawal during that timeframe.

Participants will undergo physical, behavioral and developmental examinations as well as stool sampling.

After the initial 14-week trial period, all participants will have the opportunity to take the investigational medication as part of an open-label study.

Refer:

To refer a child to the blüm study, contact Study Coordinator Emily Zetzer at 216.448.6682 or email zetzere@ccf.org.