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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a customized probiotic, called Flore, affects individuals with autism, focusing on changes in autism symptoms and digestive issues. Participants will receive a probiotic tailored to their gut bacteria. It suits new clients of Sun Genomics with an autism diagnosis who have not yet started treatment. Participants should not have used antibiotics or changed medications or supplements in the past two months. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative probiotic.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that probiotics, like the one under study, can be safe for people with autism. One study found that children with autism who took probiotics showed improvements in behavior and gut issues. Importantly, no side effects were reported, indicating the treatment was well-tolerated.

Other studies suggest that probiotics can help balance the gut microbiome, the community of bacteria in the intestines, and might improve autism-related symptoms. Overall, the evidence suggests that this approach could be safe and helpful, though more research is needed to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Researchers are excited about Flore because it uses a personalized approach to treating autism by customizing probiotics based on each individual's microbiota. Unlike traditional treatments for autism, which often include behavioral therapies and medications aimed at managing symptoms, Flore targets the gut-brain connection, an area gaining interest for its potential impact on neurological conditions. By tailoring probiotics specifically to a person's unique microbiota, Flore aims to address underlying biological factors, potentially leading to more effective and individualized treatment outcomes.

What evidence suggests that this treatment might be an effective treatment for autism?

Research has shown that probiotics might help people with autism by improving gut health and related issues. Studies have found that children with autism who took probiotics for three months experienced better digestive health and fewer stomach problems. Another study found that probiotics improved both behavior and stomach issues in children with autism, with no reported side effects. Additionally, precision synbiotics, which include probiotics, have been shown to increase the variety of beneficial bacteria in the gut, potentially aiding autism-related symptoms. These findings suggest that probiotics like Flore, provided in this trial as a customized treatment based on participants' microbiota, could benefit people with autism by addressing both digestive and autism-related issues. ^{2 3 5 6 7}

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?

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+

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.

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11097633/

Precision synbiotics increase gut microbiome diversity and ... In summary, we found that precision synbiotics modulated the gut microbiome and could be used as supplementation to improve gastrointestinal and ASD-related ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10060862/

A review of probiotics in the treatment of autism spectrum ... Children with ASD aged 5–9 years who received probiotic supplements for 3 months showed improvements in their GI microbiota, GI symptoms, and ...

3. bmjpaedsopen.bmj.com bmjpaedsopen.bmj.com/content/9/1/e003045

Impact of probiotic supplements on behavioural and ... Probiotic supplementation improved both behavioural and GI symptoms in children with ASD and was well-tolerated, with no adverse events reported.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02903030

Probiotics for Quality of Life in Autism Spectrum Disorders A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder (ASD), targeting gastrointestinal (GI) symptoms.

5. flore.com flore.com/blogs/learn/autism-microbiota-transfer?srsltid=AfmBOoqhwhYGd48cUv27yit3kNA8IvzSHV_uPVu0RFOvz2AAaOtuY_gO

Autism Research & Advances Using Microbiota Transfer In an open-label trial with eighteen participants, the therapy provided improvements for GI symptoms, autism-related symptoms, microbial ...

6. flore.com flore.com/products/flore-pathways?srsltid=AfmBOoopjJw6lvmTkqEhF6S_3Yux2Eim12F7PuSIV9YbcDd1a-2uXaal

Floré Pathways & Supportive Autism Spectrum Probiotics Pathways supports gut health, metabolism & well-being with probiotics aiding microbiome balance, thiamine & GABA levels for those on the autism spectrum.

7. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2023.1123462/full

A review of probiotics in the treatment of autism spectrum ... This review suggests that probiotic administration to regulate the gut–brain axis might improve gastrointestinal symptoms, restore ASD-related behavioral ...