What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that involve modulation of gut microbiota, such as probiotics, generally have a good safety profile with few side effects. The most frequently reported side effects are mild and include gastrointestinal symptoms like bloating, gas, and diarrhea. These treatments are considered safe for both prenatal and postnatal periods in healthy individuals. However, the effectiveness and specific outcomes can vary depending on the probiotic strains used.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting gut microbiota modulation for Autism Spectrum Disorder (ASD). The FDA has approved medications such as risperidone and aripiprazole to address irritability associated with ASD, but these do not focus on gut microbiota. Research into probiotics and other gut microbial-based treatments is ongoing, but these have not yet received FDA approval for ASD treatment.

What other types of research exist?

Promising, novel alternatives to customized probiotics for ASD patients include prebiotics, vitamin A supplementation, antibiotics, and fecal microbiota transplantation (FMT). These interventions have shown potential in modulating gut microbiota and improving both behavioral and gastrointestinal symptoms in children with ASD.

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Probiotic

Probiotics for Autism

Q: What is the mechanism of action of this treatment?

Probiotics, a common treatment for Autism Spectrum Disorder (ASD), work by modulating the gut microbiota. This modulation can improve gastrointestinal symptoms, which are frequently observed in ASD patients. Additionally, altering the gut microbiota can impact the gut-brain axis, potentially reducing core ASD symptoms such as social-affective behaviors. These improvements are significant for ASD patients as they can enhance overall quality of life and adaptive functioning.

Phase < 1

Waitlist Available

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children and adults ages 2.5-75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in score between baseline and 3 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, probiotics typically may cause digestive discomfort initially such as gas or bloating; however, they're generally considered safe. Any unexpected reactions would be documented throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between the ages of 2.5 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in score between baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in score between baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in score between baseline and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Parent Global Impressions of Autism

Secondary study objectives

Gastrointestinal Symptom Rating Scale

Social Responsiveness Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Each participant receives a customized probiotic based on the results of the test of their microbiota

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Probiotics, a common treatment for Autism Spectrum Disorder (ASD), work by modulating the gut microbiota. This modulation can improve gastrointestinal symptoms, which are frequently observed in ASD patients. Additionally, altering the gut microbiota can impact the gut-brain axis, potentially reducing core ASD symptoms such as social-affective behaviors. These improvements are significant for ASD patients as they can enhance overall quality of life and adaptive functioning.

Effects of gut microbial-based treatments on gut microbiota, behavioral symptoms, and gastrointestinal symptoms in children with autism spectrum disorder: A systematic review.Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial.Role of Probiotics in Managing Gastrointestinal Dysfunction in Children with Autism Spectrum Disorder: An Update for Practitioners.