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

Eric Hollander, Genoveva Uzunova, Bonnie P. Taylor, Rachel H. Noone, Emma Racine, Ellen Doernberg, Katherine Freeman, Casara Jean Ferretti

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
JournalWorld Journal of Biological Psychiatry
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Trichuris
Cross-Over Studies
Ovum
Placebos
Food Hypersensitivity
Immunologic Factors
Feasibility Studies
Therapeutics
Autism Spectrum Disorder
Communication
Medicine
Safety

Keywords

  • Autism spectrum disorder
  • cytokines
  • pharmacotherapy
  • repetitive behaviors
  • Trichuris suis ova

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder. / Hollander, Eric; Uzunova, Genoveva; Taylor, Bonnie P.; Noone, Rachel H.; Racine, Emma; Doernberg, Ellen; Freeman, Katherine; Ferretti, Casara Jean.

In: World Journal of Biological Psychiatry, 01.01.2018.

Research output: Contribution to journalArticle

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AU - Doernberg, Ellen

AU - Freeman, Katherine

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