High-protease pancreatic therapy shows promise in easing autism behaviors in preschoolers

A cohort study involving preschool-aged children with autism spectrum disorder (ASD) has shown promising results in reducing maladaptive behaviors, particularly irritability, through the use of high-protease pancreatic therapy (CM-AT).

The study, which started in 2015 and concluded data collection in 2021, involved a double-blind parallel group with a delayed-start design. The treatment spanned 12 weeks, including a 2-week blinded placebo run-in, and a subsequent double-blind, randomized, placebo-controlled segment.

All 190 children (mean age 4.5) were randomly assigned to receive either 900 mg of high-protease pancreatic replacement therapy or a placebo 3 times a day for 12 weeks. Following this, all participants received 900 mg of high-protease pancreatic replacement therapy for an additional 24 weeks.

The primary outcome was measured using the irritability/agitation subscale of the Aberrant Behavior Checklist (ABC-I). The results of the mixed model for repeated measures analysis demonstrated statistically significant differences of -2.49 (95% CI, -4.66 to -0.32; Cohen d = 0.364; P = 0.03) at the 12-week time point and -3.07 (95% CI, -5.81 to -0.33; Cohen d = 0.516; P = 0.03) at the 36-week time point. The CM-AT was well-tolerated with no emergent safety concerns or related serious adverse events noted.

Reference
Pearson DA, Hendren RL, Heil MF, et al. Pancreatic Replacement Therapy for Maladaptive Behaviors in Preschool Children With Autism Spectrum Disorder. JAMA Netw Open. 2023;6(11):e2344136. doi: 10.1001/jamanetworkopen.2023.44136. PMID: 38032645; PMCID: PMC10690476.