CLINICAL TRIAL

Fecal Microbiota Transplant for Autistic Disorder

Waitlist Available · Any Age · All Sexes · Ventura, CA

This study is evaluating whether fecal transplantation may help improve social deficits and language delays in individuals with autism spectrum disorder.

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About the trial for Autistic Disorder

Eligible Conditions
Autism Spectrum Disorder · Child Development Disorders, Pervasive · Autism, Early Infantile · Autistic Disorder

Treatment Groups

This trial involves 2 different treatments. Fecal Microbiota Transplant is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Fecal Microbiota Transplant
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant
2014
Completed Phase 3
~160

Eligibility

This trial is for patients born any sex of any age. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
Stable medications during the two months prior to enrollment.
Subject at least two years of age.
Currently receiving interventions in the community or school for ASD.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 52 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 52 Weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Fecal Microbiota Transplant will improve 2 primary outcomes and 5 secondary outcomes in patients with Autistic Disorder. Measurement will happen over the course of 52 Weeks.

Shannon Diversity Index
52 WEEKS
Changes in Shannon Diversity index compared between pre and post FMT scores
Serious Adverse Events
52 WEEKS
Number of participants with serous adverse events
SRS-II
52 WEEKS
Number of participants with changes in Social Responsiveness Scale scores
ATEC
52 WEEKS
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
CARS-2
52 WEEKS
Number of participants with changes in Childhood Autism Rating Scale 2 scores
Adverse Events
52 WEEKS
Number of participants with grade III or higher adverse events
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for autistic disorder?

This information should be important for all health professionals caring for autistic child/adults and should help to define the treatment landscape. In addition, information on this topic can help to provide accurate information to parents/guardians of these individuals.

Anonymous Patient Answer

Can autistic disorder be cured?

Early identification and aggressive intervention with a multidisciplinary team can improve people's quality of life, the outcomes of special education and reduce some of the disability associated with ASD.

Anonymous Patient Answer

What is autistic disorder?

Autistic disorder is a neurodevelopmental disorder characterized by severe language delay, social deficits, and repetitive behaviour. A diagnosis should be reconsidered at the primary care level when a child has developmental deficits, atypical language development, repetitive, stereotyped or ritualistic behaviour, and lack of interest, and is not responding to early intervention.

Anonymous Patient Answer

What causes autistic disorder?

In a recent study, findings contribute data to the existing hypotheses and to the notion that ASDs may arise in families where other relatives have had psychiatric illnesses but when the family history contains no such diagnoses. In a recent study, findings also question the existence of a distinct 'core AS population' with autistic psychopathology restricted to only a few members, as proposed by the 'extreme male brains' hypothesis.

Anonymous Patient Answer

What are the signs of autistic disorder?

Autistic people often have issues with social interaction, inappropriate play with toys or talking too rapidly, which might cause them to appear to be behaving strangely. In the UK, there are certain behaviours, such as hand flapping, that imply autistic behaviour. Other behaviours that people might notice are staring with a blank look or seeming to focus just an inch or two from someone. Other behaviours include looking only at one object or in an area for long periods or appearing not to notice other people in their environment. In many areas, they do not seem to respond to other people's emotional states, such as smiles and pointing.

Anonymous Patient Answer

How many people get autistic disorder a year in the United States?

An estimated 70,000 people are diagnosed with autism spectrum disorder each year in the United States. The rate of diagnosis in the United States exceeds rates in Western Europe and is about one-third the rate in Japan.

Anonymous Patient Answer

Does autistic disorder run in families?

There is a slight but statistically significant association between a child's diagnostic status and that of his or her siblings. The implication is that autistic spectrum disorders appear to run in families and that autistic disorder has multiple etiologic pathways.

Anonymous Patient Answer

Who should consider clinical trials for autistic disorder?

Clinical trials are an important resource for families searching for a cure for (autistic) disorder. A good trial will take a family from their pre-clinical stage to their post-primal stage, and include a standardized statistical analysis. It is highly recommended that a clinical trial be planned as part of the clinical team's work plan for autism. It should be considered within the context of a multi-disciplinary setting, particularly an environment with a high-quality research focus along with clinical care providers with the expertise and flexibility to tailor the trial to the family's needs.

Anonymous Patient Answer

Has fecal microbiota transplant proven to be more effective than a placebo?

Results from a recent clinical trial supports the use of FMTs for treatment of patients with recurrent C. difficile infections. Furthermore, the results suggest that patients should not be prescribed alternative treatment regimens without prior medical consultation and consent because the risks of non-responsiveness to the regimen and the higher chances of relapse due to antibiotic resistance are not fully addressed.

Anonymous Patient Answer

What are the latest developments in fecal microbiota transplant for therapeutic use?

Current research demonstrates the safety and possible efficacy of FMT in the treatment of several gastrointestinal and autoimmune disorders but no standard method of stool donation has yet emerged, thus limiting its utility for FMT within clinical settings.

Anonymous Patient Answer

What is the primary cause of autistic disorder?

Because autistic disorders appear so nonuniform, the two leading hypotheses of autistic disorder are that autism is due to a genetic disorder or to a disease process that causes pervasive developmental delay. The authors summarize evidence that suggests these two hypotheses both require modification. The evidence presented in this article is that autism may share pathophysiology with pervasive developmental disorders, particularly childhood schizophrenia.

Anonymous Patient Answer

How serious can autistic disorder be?

Autistic disorder is highly correlated with ADHD in children, and can cause serious consequences, not only for the child, but for the parents, the society, and the whole world. Clinicians need to assess and understand this condition to help these children more effectively.

Anonymous Patient Answer
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