Probiotics for Autism and Stress in Children

Overseen By Gesulla Cavanaugh, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Must be taking: Children's probiotics

Disqualifiers: Severe cognitive impairment, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

75 Participants Needed

Trial Summary

What is the purpose of this trial?

Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Probiotic, Beneficial bacteria, Live cultures, Microbial supplements for autism and stress in children?

Research suggests that probiotics may help improve gastrointestinal symptoms and some behavioral aspects in children with autism. In some studies, children with autism who took probiotics showed improvements in communication skills, reduced anxiety, and better sleep, indicating potential benefits of probiotics in managing autism symptoms. ^{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. No serious adverse events were noted, and some studies even found fewer non-serious side effects with probiotics compared to placebo. ^{1 4 6 7 8}

How do probiotics differ from other treatments for autism in children?

Probiotics are unique in treating autism by targeting the gut-brain connection, potentially improving both gastrointestinal and behavioral symptoms by restoring healthy gut bacteria balance, unlike traditional treatments that focus directly on behavioral interventions or medications. ^{1 4 5 7 9}

Research Team

Gesulla Cavanaugh, PhD

Principal Investigator

Nova Southeastern University

Eligibility Criteria

This trial is for children with Autism Spectrum Disorder or those who have experienced repeated stress, including stress fractures and adverse childhood experiences. It aims to compare these groups with a control group of children without these conditions.

Inclusion Criteria

Children in homeless shelters

Children diagnosed with Autism

Children in foster care

Exclusion Criteria

My child is not between 4 and 7.9 years old.

I have significant memory or thinking problems.

I cannot watch a screen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Initial assessment including eye-tracking and heart rate measurement, and collection of stool and saliva samples

1 day

1 visit (in-person)

Probiotic Treatment

Optional incorporation of probiotics, multivitamins, and dietary changes for 4 weeks

4 weeks

No additional visits required

Follow-up Assessment

Follow-up assessment including eye-tracking and heart rate measurement, and collection of stool and saliva samples after 4 weeks

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Probiotic

Trial Overview The study is testing whether taking probiotics can influence the gut microbiome and how this might be associated with stress responses and cognitive functions in children, using advanced techniques like metabolomics and eye-tracking.

Participant Groups

Group I: Probiotic Treatment Experimental Treatment 1 Intervention

Pediatric Probiotic Treatment

Group II: No Probiotic Treatment Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Findings from Research

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]

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]

A randomized double-blind crossover study involving 61 children with autism spectrum disorders (ASDs) found that a mixture of probiotics significantly improved gastrointestinal symptoms, communication skills, maladaptive behaviors, and reduced parental stress levels.

The study supports the connection between gut health and ASDs, highlighting specific probiotic strains like Streptococcus thermophilus and Bifidobacterium longum that may positively influence behavioral outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Double-Blind Crossover Study for Evaluating a Probiotic Mixture on Gastrointestinal and Behavioral Symptoms of Autistic Children. Guidetti, C., Salvini, E., Viri, M., et al.[2022]

In a study of 40 children with autism spectrum disorder (ASD) aged 2-5 years, a 3-month probiotic supplementation significantly increased beneficial gut bacteria (Bifidobacterium spp. and Lactobacillus spp.), indicating a positive effect on gut health.

The probiotic treatment was associated with reduced anxiety and improved sleep in 80% of the children, suggesting that probiotics may help alleviate some symptoms of ASD and improve overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Characterization of Probiotics and Their Influence on Children with Autism Spectrum Disorder. Meguid, NA., Mawgoud, YIA., Bjørklund, G., et al.[2022]

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]

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]

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]

References

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized Double-Blind Crossover Study for Evaluating a Probiotic Mixture on Gastrointestinal and Behavioral Symptoms of Autistic Children. [2022]

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

Molecular Characterization of Probiotics and Their Influence on Children with Autism Spectrum Disorder. [2022]

5. Egypt pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

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