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Trichuris Suis Ova in Autism Spectrum Disorders (TSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01040221
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Simons Foundation
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE December 24, 2009
First Posted Date  ICMJE December 29, 2009
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2009)
  • Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors [ Time Frame: baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks ]
  • Aberrant Behavior Checklist (ABC): to measure aggression and irritability [ Time Frame: baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks ]
  • Clinical Global Impression - Improvement (CGI-I): to measure global functioning [ Time Frame: baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2009)
Repetitive Behavior Scale-Revised. [ Time Frame: baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trichuris Suis Ova in Autism Spectrum Disorders
Official Title  ICMJE Trichuris Suis Ova in Autism Spectrum Disorders
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE Drug: Trichuris Suis Ova
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.
Study Arms  ICMJE
  • Experimental: Trichuris Suis Ova (TSO)
    the eggs of intestinal helminthes (trichuris suis ova) administered as 2500 ova doses every two weeks.
    Intervention: Drug: Trichuris Suis Ova
  • Placebo Comparator: Placebo
    placebo dosage received every two weeks.
    Intervention: Drug: Trichuris Suis Ova
Publications * Hollander E, Uzunova G, Taylor BP, Noone R, Racine E, Doernberg E, Freeman K, Ferretti CJ. Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder. World J Biol Psychiatry. 2020 Apr;21(4):291-299. doi: 10.1080/15622975.2018.1523561. Epub 2018 Nov 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2009)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-35, inclusive, at the time of consent
  2. Outpatient
  3. Meet criteria for the diagnosis of Autism Spectrum Disorder according to the DSM-IV-TR, and supported by the ADOS or ADI-R.
  4. Have an IQ of 70 or greater
  5. Participants who are taking other medications prior to enrollment must be on a stable dose of concomitant medication, including psychotropic, anticonvulsant, or sleep aid for at least 3 months prior to baseline ratings
  6. Be judged reliable for medication compliance and agree to keep appointments for study contacts and tests as outlined in the protocol (both subjects and guardians)
  7. Have a personal or family history of allergies.

Exclusion Criteria:

  1. History of Bipolar disorder or Psychotic Disorders (e.g. schizophrenia or schizoaffective disorders).
  2. Previous diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
  3. Uncontrolled seizure disorders (seizures within the past 6 months)
  4. Pregnant or breast feeding at screening, or at any time during the study
  5. Chronic medical illness that would interfere with or contraindicate participation in the study, or clinically significant abnormalities in baseline laboratory testing or physical exam.
  6. Treatment in the last 12 weeks with cyclosporine, methotrexate, infliximab or immunomodulatory agents
  7. Treatment in the last 2 weeks with antibiotics, antifungal or antiparasitic medications
  8. Presence of any organic or systemic disease or need for a therapeutic intervention, which would confound the interpretation of results.
  9. History of previous treatment with Trichuris Suis Ova (TSO).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01040221
Other Study ID Numbers  ICMJE 11-11-384
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Hollander, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Simons Foundation
Investigators  ICMJE
Principal Investigator: Eric Hollander, MD Montefiore Medical Center/Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP