Probiotics for Autism

Overseen By James B. Adams, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Arizona State University

Must not be taking: Antibiotics

Disqualifiers: Recent medication changes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

350 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 10 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Sun Genomics

Collaborator

Trials

2

Recruited

410+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of probiotics in the management of childhood autism spectrum disorders. Critchfield, JW., van Hemert, S., Ash, M., et al.[2022]

Probiotics have shown potential benefits in improving gastrointestinal symptoms and correcting gut microbiota imbalances in individuals with autism spectrum disorder (ASD), which may also help reduce the severity of behavioral symptoms.

The review highlights the need for more rigorous research, including randomized controlled trials with larger populations and standardized methods, to better understand the mechanisms by which probiotics may alleviate both gastrointestinal and behavioral symptoms in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Promising Role of Probiotics in Managing the Altered Gut in Autism Spectrum Disorders. Abdellatif, B., McVeigh, C., Bendriss, G., et al.[2021]

In a double-blind, placebo-controlled trial involving 85 preschoolers with Autism Spectrum Disorder (ASD), probiotics did not show significant effects on the overall autism severity scores for the entire group, indicating limited efficacy in the general population studied.

However, in children without gastrointestinal symptoms, those treated with probiotics showed a significant reduction in autism severity scores, suggesting that probiotics may benefit specific subgroups of children with ASD, particularly those without GI issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial. Santocchi, E., Guiducci, L., Prosperi, M., et al.[2022]

The pilot trial involving 13 children with autism spectrum disorder (ASD) showed that the probiotic VISBIOME was safe and led to improvements in gastrointestinal symptoms, with no serious adverse events reported.

While the overall quality of life scores (PedsQL) did not reach statistical significance, there was a notable improvement in GI complaints with the probiotic compared to placebo, suggesting potential benefits that merit further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial. Arnold, LE., Luna, RA., Williams, K., et al.[2020]

In a study involving 131 autistic children and adolescents, the use of the probiotic Lactobacillus plantarum PS128 led to significant improvements in symptoms of Autism Spectrum Disorder with very few side effects.

Younger children showed more pronounced benefits from Lactobacillus plantarum PS128 compared to other probiotics, supporting its specific efficacy in managing symptoms of autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus plantarum PS128 and Other Probiotics in Children and Adolescents with Autism Spectrum Disorder: A Real-World Experience. Mensi, MM., Rogantini, C., Marchesi, M., et al.[2021]

Probiotic therapy shows promising potential in improving gastrointestinal symptoms and altering gut microbiota in children with autism spectrum disorder (ASD), based on a review of 5 studies involving 117 children.

Despite the encouraging results, further research is needed to address methodological flaws and to determine the best probiotic species, strains, dosages, and treatment duration for optimal effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Probiotics in Managing Gastrointestinal Dysfunction in Children with Autism Spectrum Disorder: An Update for Practitioners. Patusco, R., Ziegler, J.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Prebiotics and probiotics for autism spectrum disorder: a systematic review and meta-analysis of controlled clinical trials. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Effect of probiotics combined with applied behavior analysis in the treatment of children with autism spectrum disorder: a prospective randomized controlled trial. [2023]

3. Egypt pubmed.ncbi.nlm.nih.gov

The potential role of probiotics in the management of childhood autism spectrum disorders. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Promising Role of Probiotics in Managing the Altered Gut in Autism Spectrum Disorders. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Lactobacillus plantarum PS128 and Other Probiotics in Children and Adolescents with Autism Spectrum Disorder: A Real-World Experience. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Role of Probiotics in Managing Gastrointestinal Dysfunction in Children with Autism Spectrum Disorder: An Update for Practitioners. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Amelioration of Maternal Immune Activation-Induced Autism Relevant Behaviors by Gut Commensal Parabacteroides goldsteinii. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Lactiplantibacillus plantarum N-1 improves autism-like behavior and gut microbiota in mouse. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Selective Probiotic Treatment Positively Modulates the Microbiota-Gut-Brain Axis in the BTBR Mouse Model of Autism. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Characterization of Intestinal Microbiota and Probiotics Treatment in Children With Autism Spectrum Disorders in China. [2020]