Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder.

Abstract

Objectives: Inflammatory mechanisms are implicated in the aetiology of autism spectrum disorder (ASD), and use of the immunomodulator Trichuris suis Ova (TSO) is a novel treatment approach. This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD.Methods: A 28-week double-blind, randomised two-period crossover study of TSO versus placebo in ten ASD adults, aged 17-35, was completed, with a 4-week washout between each 12-week period at Montefiore Medical Center, Albert Einstein College of Medicine. Subjects with ASD, history of seasonal, medication or food allergies, Y-BOCS ≥6 and IQ ≥70 received 2,500 TSO ova or matching placebo every 2 weeks of each 12-week period.Results: Large effect sizes for improvement in repetitive behaviours (d = 1.0), restricted interests (d = 0.82), rigidity (d = 0.79) and irritability (d = 0.78) were observed after 12 weeks of treatment. No changes were observed in the social-communication domain. Differences between treatment groups did not reach statistical significance. TSO had only minimal, non-serious side effects.Conclusions: This proof-of-concept study demonstrates the feasibility of TSO for the treatment of ASD, including a favourable safety profile, and moderate to large effect sizes for reducing repetitive behaviours and irritability.Clinicaltrials.gov: NCT01040221.

• Authors: Eric Hollander, Genoveva Uzunova, Bonnie P Taylor, Rachel Noone, Emma Racine, Ellen Doernberg, Katherine Freeman, Casara Jean Ferretti
• Journal: The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry (World J Biol Psychiatry) Vol. 21 Issue 4 Pg. 291-299 (04 2020) ISSN: 1814-1412 [Electronic] England
• PMID: 30230399 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Adolescent
• Adult
• Animals
• Autism Spectrum Disorder (complications, parasitology, therapy)
• Behavior (physiology)
• Cross-Over Studies
• Double-Blind Method
• Feasibility Studies
• Humans
• Hypersensitivity (complications, therapy)
• Irritable Mood (physiology)
• Ovum
• Pilot Projects
• Therapy with Helminths (standards)
• Trichuriasis
• Trichuris (physiology)
• Young Adult