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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether probiotics (beneficial bacteria) can reduce stress-related symptoms in children with autism and those exposed to repeated stress, such as kids in foster care or homeless shelters. Researchers examine how the gut and brain might work together to influence stress in these children. The study includes two groups: one taking probiotics and the other not receiving any probiotics. Children aged 4-7 who can watch a short video and take probiotics for four weeks may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of probiotics for stress reduction in children.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that probiotics are generally safe for children with autism, including types like Lactobacillus and Bifidobacterium. Studies have found that these probiotics are well-tolerated by children. Specifically, one study found no negative side effects when children with autism took probiotics.

Moreover, probiotics have been associated with improvements in behavior and gut health in these children, suggesting benefits beyond safety. Overall, probiotics appear to be a safe choice for children in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for autism and stress in children, which often include medication and therapy, this new approach uses probiotics. The unique feature of probiotics is that they work by potentially balancing the gut microbiome, which researchers believe may be linked to brain function and stress levels. This is exciting because it offers a natural, non-invasive option that could complement existing therapies without the side effects often associated with medications. Researchers are hopeful that probiotics might provide a gentle yet effective way to support children with these conditions.

What evidence suggests that probiotics might be an effective treatment for autism and stress in children?

Research has shown that probiotics might help improve symptoms in children with autism. Studies have found that probiotics can positively change the balance of gut bacteria, which is often imbalanced in children with autism spectrum disorder (ASD). For example, one study found that children with ASD who took probiotics had better gut health and behavior. Another study noted significant behavioral improvements with probiotic use. Additionally, children have tolerated probiotics well, with no major side effects reported. In this trial, some participants will receive probiotic treatment to evaluate its effectiveness in managing symptoms in children with autism. ^{1 3 4 5 6}

Who Is on the Research Team?

Gesulla Cavanaugh, PhD

Principal Investigator

Nova Southeastern University

Are You a Good Fit for This Trial?

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 diagnosed with Autism

Children in foster care

Children in homeless shelters

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8870536/

The role of probiotics in children with autism spectrum disorders

Recent studies suggest that microbiota change in children with ASD after the ingestion of probiotics may improve the balance of microbiota and thus ASD ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022395624005314

Probiotics for autism spectrum disorder: An updated ...

Our study highlighted the significant improvement in ASD behavioral symptoms through probiotic supplementation.

3.

withpower.com

withpower.com/trial/phase-autism-spectrum-disorder-2023-7641c

Probiotics for Autism and Stress in Children

Probiotics have shown potential benefits in improving gastrointestinal symptoms and correcting gut microbiota imbalances in individuals with autism spectrum ...

4.

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.

5.

frontiersin.org

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

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 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02903030

Probiotics for Quality of Life in Autism Spectrum Disorders

The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.