Trichuris Suis Ova Adult Autism Symptom Domains

2014-08-27 03:16:59 | BioPortfolio


The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with serious behavioral problems related to autism.


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 16 week, open-label trial of TSO to assess the effect on repetitive behaviors, aggression and irritability, and global functioning in adults with autistic 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care




Trichuris Suis Ova


Mount Sinai School of Medicine
New York
New York
United States




Mount Sinai School of Medicine

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:16:59-0400

Clinical Trials [363 Associated Clinical Trials listed on BioPortfolio]

Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response an...

Immune Modulation From Trichuris Suis

Mucosal immunology during helminth infection

Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.

Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)

The PROCTO trial is a double-blind randomized, placebo-controlled, 24-week, comparative, exploratory phase II proof of concept trial. The trial will be conducted with 2 treatment groups as...

Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura

The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will...

PubMed Articles [655 Associated PubMed Articles listed on BioPortfolio]

Randomized Crossover Feasibility Trial of Helminthic Trichuris Suis Ova vs. Placebo for Repetitive Behaviors in Adult Autism Spectrum Disorder.

Inflammatory mechanisms are implicated in the etiology of Autism Spectrum Disorder (ASD), and use of the immunomodulator Trichuris Suis Ova (TSO) is a novel treatment approach. This pilot study determ...

Methods for the detection and characterization of Streptococcus suis: from conventional bacterial culture methods to immunosensors.

One of the most important zoonotic pathogens worldwide, Streptococcus suis is a swine pathogen that is responsible for meningitis, toxic shock and even death in humans. S. suis infection develops rapi...

A Streptococcus suis live vaccine suppresses streptococcal toxic shock-like syndrome and provides sequence type independent protectionTITLE.

Streptococcus suis (S. suis) is an encapsulated zoonotic pathogen. Increasing antimicrobial resistance invokes the need for effective vaccines. Despite many attempts to develop an effective vaccine, n...

Immunogenicity and protective capacity of EF-Tu and FtsZ of Streptococcus suis serotype 2 against lethal infection.

Vaccine development efforts against Streptococcus suis serotype 2 (S. suis 2) are often constrained by strain/serotype antigen variability. Bioinformatics analyses revealed two highly conserved S. sui...

Silibinin attenuates Streptococcus suis serotype 2 virulence by targeting suilysin.

To determine the anti-virulence properties of silibinin against suilysin (SLY), a virulence factor of Streptococcus suis serotype 2 (SS2) that plays an important role in the pathogenesis of S. suis in...

Medical and Biotech [MESH] Definitions

A childhood disorder predominately affecting boys and similar to autism (AUTISTIC DISORDER). It is characterized by severe, sustained, clinically significant impairment of social interaction, and restricted repetitive and stereotyped patterns of behavior. In contrast to autism, there are no clinically significant delays in language or cognitive development. (From DSM-IV)

A genus of nematode worms comprising the whipworms.

Infection with nematodes of the genus TRICHURIS, formerly called Trichocephalus.

A species of gram-negative bacteria, primarily infecting SWINE, but it can also infect humans, DOGS, and HARES.

A species of STREPTOCOCCUS isolated from pigs. It is a pathogen of swine but rarely occurs in humans.

More From BioPortfolio on "Trichuris Suis Ova Adult Autism Symptom Domains"

Quick Search


Relevant Topics

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Autism affects half a million people in the UK. Men are affected more than women. People with autism have said that the world, to them, is a mass of people, places and events which they struggle to make sense of, and which can cause them considerable a...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Trial