Trichuris Suis Ova in Autism Spectrum Disorders

Completed · Phase 1 · Has a placebo group

Conditions studied: Autism

In brief

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

Key facts

Study ID

NCT01040221

Run by

Montefiore Medical Center

People needed

10

Starts

2012-11-01

Expected to finish

2014-07-01

Last updated by the study team

2018-04-03

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-35, inclusive, at the time of consent
• Outpatient
• Meet criteria for the diagnosis of Autism Spectrum Disorder according to the DSM-IV-TR, and supported by the ADOS or ADI-R.
• Have an IQ of 70 or greater
• 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
• 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)
• Have a personal or family history of allergies.

You may not qualify if…

• History of Bipolar disorder or Psychotic Disorders (e.g. schizophrenia or schizoaffective disorders).
• Previous diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
• Uncontrolled seizure disorders (seizures within the past 6 months)
• Pregnant or breast feeding at screening, or at any time during the study
• Chronic medical illness that would interfere with or contraindicate participation in the study, or clinically significant abnormalities in baseline laboratory testing or physical exam.
• Treatment in the last 12 weeks with cyclosporine, methotrexate, infliximab or immunomodulatory agents
• Treatment in the last 2 weeks with antibiotics, antifungal or antiparasitic medications
• Presence of any organic or systemic disease or need for a therapeutic intervention, which would confound the interpretation of results.
• History of previous treatment with Trichuris Suis Ova (TSO).

Where it is running

• Montefiore Medical Center, Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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