Preliminary phase 2 clinical trials revealed improved social interaction in some children after secretin administration
Oregon Health & Science University is one of 20 national centers participating in a clinical trial of secretin, a naturally-occurring hormone, as a possible treatment for autism in children. The study exclusively includes children between two-years, eight months old and four-years, eleven months old, and is based on preliminary research showing some improvements in social interaction in three- and four-year-olds with autism.
A synthetic form of the naturally occurring hormone, secretin, was evaluated previously in a phase 2 clinical trial. This trial was the first to suggest the hormone was connected to some improvements in autistic children. The study evaluated the impact of three doses of secretin in young children with autism, and found no serious side effects from intravenous administration. The synthetic hormone is supplied by the company Repligen.
Although effects of secretin are most significant in the abdomen, where the hormone aids digestion, it is thought the hormone may play a role in autism for several reasons. It is common for children with autism to also display gastrointestinal symptoms, which may be related to secretin deficiency.
The phase 3 trial at OHSU is ongoing and actively recruiting participants, who must be between two-years, eight months old and four-years, eleven months old. Other requirements include language delay and gastrointestinal problems. Participants cannot have any other known neurologic or genetic disorder, and final screening for inclusion in the study is based on blood, urine and fecal testing, as well as behavioral assessments.
The study includes 11 visits over five months, and participants may be placed in either a group receiving secretin or a group receiving placebo (there is a 50 percent chance of being placed in either group). Interested parents can contact Kathy Henley, 503 494-1404, for more information.