Trichuris Suis Ova in Autism Spectrum Disorders
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and
      effective in treating adults with autism spectrum disorder
    

Detailed description: 
      Autism is a pervasive developmental disorder affecting social, communicative, and
      compulsive/repetitive behaviors. It is also frequently accompanied by aggression,
      self-injury, and irritability, making care for these individuals a significant challenge for
      families or institutional settings. Currently risperidone is the only medication approved by
      the Food and Drug Administration (FDA) for irritability associated with autism, although not
      all patients respond to risperidone or are able to tolerate its side effects. As such,
      additional targeted treatments need to be explored in autism. Neuroimmune disturbance has
      been demonstrated in patients with autism (Ashwood et al., 2006; DelGuidice, 2003) and the
      presence of neuroinflammation may play a role in initiating or maintaining CNS dysfunction
      characteristic of the disorder (Pardo et al, 2005). Therefore, there is considerable interest
      in using immunomodulatory medications to address core and associated symptoms.

      Trichuris suis ova (TSO) are the eggs of intestinal helminthes which induce Th2 cytokine
      release and nonspecifically downregulate Th1 responsiveness (Summers et al., 2003). Treatment
      with TSO has been shown to have a beneficial effect in autoimmune inflammatory bowel disease
      (Summers et al, 2003; Summers et al., 2005a; Summers et al., 2005b) and anecdotal reports
      from patients with autism have demonstrated that TSO may be effective in reducing repetitive
      behaviors, aggression, self-injury, and impulsivity.

      To date, many medications have been used in individuals with autism and the history of
      psychopharmacology of autism is notable for the exaggerated benefit of a variety of
      treatments. To date, most medication studies in the field have been open-label without use of
      a placebo control and without systematic behavioral assessments. The current practice of
      prescribing medications to patients with autism without scientifically demonstrated efficacy
      underscores the necessity for methodologically rigorous studies to be conducted.

      We propose a double blind placebo-controlled crossover trial of TSO, where subjects would be
      randomized to receive placebo or TSO for 12 weeks, with a 4 week washout and then 12 weeks of
      the the treatment not yet received. To assess the effect on social cognition, repetitive
      behaviors, aggression and irritability, and global functioning in adults with autism spectrum
      disorder. The objectives of the proposed study are to develop an innovative treatment
      approach to autism by 1) assessing the safety and efficacy of TSO treatment using behavioral
      and laboratory outcome measures; 2) determining whether this treatment has sufficient promise
      to warrant consideration of a larger, multi-centered, placebo-controlled clinical trial; 3)
      conducting secondary analyses to explore the relationship between clinical features, immune
      mechanisms, and treatment response.
    

Intervention name(s): Trichuris Suis Ova
Intervention type(s): Drug
Intervention description(s): TSO will be administered in vials prepared by Coronado Biosciences. Vials will be diluted with a commercial drink and given to subjects to ingest. Subjects will receive a dose of 2500 ova every two weeks for 12 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism, Autism Spectrum Disorder; ASD; Trichuris Suis Ova; TSO; Treatment; Clinical Trial