350 Participants Needed

Probiotics for Autism

DC
JB
Overseen ByJames B. Adams, PhD
Age: Any Age
Sex: Any
Trial Phase: Phase < 1
Sponsor: Arizona State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a customized probiotic for children and adults with autism. The probiotic is tailored to each person's gut bacteria to see if it can help with autism and digestive symptoms. Participants will complete questionnaires at different points during the study. Probiotics have been explored in various studies for their potential to improve gastrointestinal health and reduce autism symptoms by modulating the gut-brain-microbiome axis.

Will I have to stop taking my current medications?

You won't need to stop your current medications, but you must not have changed them in the last two months and should not plan to change them during the first three months of the study.

Is probiotic treatment safe for children with autism?

Probiotic treatments, including those with Lactobacillus and Bifidobacterium species, have been shown to be generally safe for children with autism, with few side effects reported. In studies, more nonserious side effects occurred with placebo than with probiotics, and no serious adverse events were noted.12345

How does the treatment Flore differ from other treatments for autism?

Flore, a probiotic treatment, is unique because it targets the gut-brain axis, potentially improving autism symptoms by altering gut microbiota. Unlike traditional therapies, it focuses on reducing inflammation and enhancing neuropeptide signaling, which may help alleviate autism-related behaviors.678910

What data supports the effectiveness of the treatment Flore for autism?

Some studies suggest that probiotics, like those in Flore, may help improve gastrointestinal issues and possibly reduce some autism symptoms in children, especially those without gastrointestinal problems. However, more research is needed to confirm these findings.48111213

Are You a Good Fit for This Trial?

This trial is for children and adults aged 2.5-75 years who have been diagnosed with Autism Spectrum Disorder (ASD). Participants must be new clients of Sun Genomics, not having started treatment yet, and their ASD diagnosis will be confirmed by an evaluation. They should not have had any medication or therapy changes in the last two months nor plan to change them during the first three months of the study.

Inclusion Criteria

The new client of Sun Genomics has applied for testing and treatment, but has not yet begun treatment.
I have been diagnosed with ASD by a doctor, confirmed by ASU staff.
I am between the ages of 2.5 and 75 years old.

Exclusion Criteria

I have not taken any antibiotics in the last two months, except for creams or ointments.
I haven't changed my medications or supplements in the last 2 months and don't plan to change them during the first 3 months of probiotic treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a customized probiotic based on their microbiota analysis

12 weeks
Initial visit for stool sample collection and questionnaire completion

Follow-up

Participants complete follow-up questionnaires to assess changes in autism and gastrointestinal symptoms

4 weeks
1 follow-up visit (virtual or in-person) for questionnaire completion

What Are the Treatments Tested in This Trial?

Interventions

  • Flore
Trial Overview The study is testing a customized probiotic called Flore on individuals with autism to see if it can improve both autism-related symptoms and gastrointestinal issues. The participants' responses to this probiotic therapy are being closely monitored.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials
311
Recruited
109,000+

Sun Genomics

Collaborator

Trials
2
Recruited
410+

Published Research Related to This Trial

A meta-analysis of clinical controlled trials found that probiotics and prebiotics did not significantly improve the severity of autism spectrum disorder (ASD) symptoms, gastrointestinal issues, or comorbid psychopathology in children.
The study highlights the need for more randomized controlled trials with larger populations and professional oversight to verify these findings, as current evidence remains limited and contradictory to previous literature.
Prebiotics and probiotics for autism spectrum disorder: a systematic review and meta-analysis of controlled clinical trials.Song, W., Zhang, M., Teng, L., et al.[2022]
In a study of 41 children with autism spectrum disorder (ASD), combining probiotics with applied behavior analysis (ABA) significantly improved behavioral symptoms compared to ABA alone, as measured by the Autism Treatment Evaluation Checklist (ATEC) after 3 months.
The addition of probiotics also led to beneficial changes in intestinal flora, increasing beneficial bacteria like Bifidobacterium and Lactobacillus while reducing harmful bacteria such as Shigella and Clostridium, suggesting a potential mechanism for the observed improvements.
Effect of probiotics combined with applied behavior analysis in the treatment of children with autism spectrum disorder: a prospective randomized controlled trial.Li, YQ., Sun, YH., Liang, YP., et al.[2023]
Children with autism spectrum disorders (ASD) often experience gastrointestinal dysfunction, which is linked to behavioral issues like irritability and sleep disturbances.
Modulating gut bacteria through probiotics may help restore normal gut microbiota and improve GI symptoms, suggesting that probiotics could be a promising therapeutic option for managing some behavioral symptoms in children with ASD.
The potential role of probiotics in the management of childhood autism spectrum disorders.Critchfield, JW., van Hemert, S., Ash, M., et al.[2022]

Citations

Prebiotics and probiotics for autism spectrum disorder: a systematic review and meta-analysis of controlled clinical trials. [2022]
Effect of probiotics combined with applied behavior analysis in the treatment of children with autism spectrum disorder: a prospective randomized controlled trial. [2023]
The potential role of probiotics in the management of childhood autism spectrum disorders. [2022]
The Promising Role of Probiotics in Managing the Altered Gut in Autism Spectrum Disorders. [2021]
Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial. [2022]
Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial. [2020]
Lactobacillus plantarum PS128 and Other Probiotics in Children and Adolescents with Autism Spectrum Disorder: A Real-World Experience. [2021]
Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters. [2022]
Role of Probiotics in Managing Gastrointestinal Dysfunction in Children with Autism Spectrum Disorder: An Update for Practitioners. [2023]
Amelioration of Maternal Immune Activation-Induced Autism Relevant Behaviors by Gut Commensal Parabacteroides goldsteinii. [2022]
Lactiplantibacillus plantarum N-1 improves autism-like behavior and gut microbiota in mouse. [2023]
Selective Probiotic Treatment Positively Modulates the Microbiota-Gut-Brain Axis in the BTBR Mouse Model of Autism. [2022]
Characterization of Intestinal Microbiota and Probiotics Treatment in Children With Autism Spectrum Disorders in China. [2020]
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