Overview

Trichuris Suis Ova in Autism Spectrum Disorders

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Montefiore Medical Center
Collaborators:
Coronado Biosciences
Simons Foundation
Criteria
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).