08:28 AM

New Autism Spectrum Disorder Trial Seeks to Address Irritability-Associated Symptoms in Teens


Carilion is one of 25 locations worldwide offering the study

Teens with autism spectrum disorder (ASD) often face significant challenges coping with irritability and aggression, including severe tantrums and deliberate self-injurious behavior at school and home. Now, Carilion is one of 25 locations worldwide offering a new study hoping to improve these patients' quality of life through the use of a novel therapeutic. 

The Tapestry Study is a clinical trial researching an experimental treatment designed to isolate certain gut-derived bacterial metabolites and reduce their ability to enter the bloodstream and reach the brain. The trial, which is based on increasing evidence of a link between gut bacteria and the brain, looks at the potential benefits, safety, and tolerability of a powder medication (AB-2004) in participants between the ages 13 to 17.

AB-2004 is a tasteless and odorless powder medication that is mixed with soft food three times a day. This study aims to assess whether lowering key gut bacterial metabolites levels can improve irritability in children with ASD. It also seeks to determine the most effective therapeutic dose.

“It’s exciting to participate in pursuing medical advances such as AB-2004,” Anita S. Kablinger, MD, CPI, primary investigator and director of clinical research for Carilion's Department of Psychiatry and Behavioral Medicine. “Many children with autism spectrum disorder experience more gastrointestinal inflammation than neurotypical kids. This study hopes to build on previous research to reduce the gut's contribution to irritability symptoms caused in the brain.”  

The study requires eligible participants to meet the following requirements:

  • 13 to 17 years of age
  • Clinically diagnosed and documented ASD
  • Stable therapeutic regimen for at least 30 days prior to screening visit
  • Not currently using antipsychotic medications

Researchers are seeking participants now. For more information on the Tapestry Study visit CarilionClinic.org