Autism Spectrum DisorderNCT06269614
Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition
A study testing Probiotic in people with Autism Spectrum Disorder and Adverse Childhood Experiences, run by Nova Southeastern University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 years to 95 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Adverse Childhood Experiences, Stress Reaction
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years to 95 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children diagnosed with Autism
- Children with neurotypical development
- Children in foster care
- Children in homeless shelters
- Children 4-7 years old
- Must be able to watch a short video
- Must be able to consume children's powder probiotics for 4 weeks
Who cannot join
- Children younger than 4, and older than 7.9 years old.
- Inability to watch a screen
- severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University College of Nursing
Davie, Florida, 33314
About this study
Official title: A Multilevel Approach to Assess the Involvement of Gut Microbiome in Autism and Childhood Stress Regulation
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.
Read the detailed description
The purpose of this study is to find out more about stress in children with autism and those who had negative experiences as children. This will help to find new ways to create therapies against stress on children with autism and those from disadvantaged backgrounds. This study is important because Adverse Childhood Experiences events put children at risk for many health issues. The aims include the examination of the involvement of the microbiome in autistic behaviors and as a modulator and response to stress in the pediatric population.
This study is significant in that many studies point to the gut microbiota as a significant mediator to brain function and behavior, while gut microbiome has been found to play a role in stress mediation. In general, microbiome studies in humans are still minimal and are even more lacking in autism and pediatric research; nonetheless, they have facilitated the evaluation of the potential connection between the microbiome and brain function. For these reasons, this research study is even more relevant in the formation of targeted and feasible strategies to find external and internal factors responsible in the buffering of stress in children from disadvantaged backgrounds, and those with autism.
The children who participate in this study will be assessed at two time points; the second time will be after 4-6 weeks from our first meeting. The parent will make the first appointment with the researcher to allow the child take part of the study. The parent will be given a survey to complete on the child and the parent. The parent will also be provided with a stool collection kit. This kit will be used for them to collect stool sample from the participating child before they come to the first and second appointments with the researcher.
The child will watch a short 2-minute video of a medium stressful scenario followed by a fun video. The child will watch the short video while the researchers evaluate the child's interest through their eye movement with an eye tracker on the computer. The child's heart rate will be measured using a Fingertip Pulse Oximeter.
During the first visit with the researcher, the parent will also receive a coupon and instructions to purchase Garden of Life Children's probiotics at the grocery store if they want their child to incorporate the probiotics in their diet for 4 weeks. They will receive instructions for the child to eat more fruits and vegetables after consulting with the child's pediatrician and/or specialist. The parent can have the researcher's recommended children's probiotics, multivitamins, more fruits and vegetables in the child's diet for 4 weeks before returning to the lab for a second observation. The child will again provide spit and stool after the 4 weeks which will be brought back to the lab during the second appointment.
- Being tested
- Probiotic
- Medical subject headings
- Autism Spectrum Disorder, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Consumption of probiotic with parent- as tolerated for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Treatment | Experimental | Pediatric Probiotic Treatment Receives: Dietary Supplement: Probiotic |
| No Probiotic Treatment | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteric Microbiome abundance
Increase in gut microbiome abundance (from stool samples) based on values from statistical methods, Analysis of Variance to compare differential abundance analysis.
Measured: 4 weeks
Enteric Microbiome diversity
Increase in gut microbiome diversity in the number of beneficial bacteria in the gut (from stool samples) as measured by α-diversity measures using plot_anova_diversity function in microbiomeSeq package.
Measured: 4 weeks
Secondary outcomes (2)
Improved response to stressor
Improved regulated stress response as assessed by salivary cortisol levels from collected saliva while watching the video stressor and the relaxation video (before the probiotics intervention and after the probiotics intervention). Cortisol levels are measured in ug/dL.
Measured: 4 weeks
Improved physiological response to stressor
Improved physiological response to stressor as measured by pulse rate (bpm) and galvanic skin response (peaks) simultaneously (before and after the probiotics intervention).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start12 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gesulla Cavanaugh, Nova Southeastern University
- Investigators
- Gesulla Cavanaugh, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269614
- Sponsor's protocol ID
- QOL334829
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared based on institutional and IRB approval
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Approach to Assess the Involvement of Gut Microbiome in Autism and Childhood Stress Regulation
- ClinicalTrials.gov ID
- NCT06269614
- Acronym / sponsor ID
- QOL334829
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to find out more about stress in children with autism and those who had negative experiences as children. This will help to find new ways to create therapies against stress on children with autism and those from disadvantaged backgrounds. This study is important because Adverse Childhood Experiences events put children at risk for many health issues. The aims include the examination of the involvement of the microbiome in autistic behaviors and as a modulator and response to stress in the pediatric population.
This study is significant in that many studies point to the gut microbiota as a significant mediator to brain function and behavior, while gut microbiome has been found to play a role in stress mediation. In general, microbiome studies in humans are still minimal and are even more lacking in autism and pediatric research; nonetheless, they have facilitated the evaluation of the potential connection between the microbiome and brain function. For these reasons, this research study is even more relevant in the formation of targeted and feasible strategies to find external and internal factors responsible in the buffering of stress in children from disadvantaged backgrounds, and those with autism.
The children who participate in this study will be assessed at two time points; the second time will be after 4-6 weeks from our first meeting. The parent will make the first appointment with the researcher to allow the child take part of the study. The parent will be given a survey to complete on the child and the parent. The parent will also be provided with a stool collection kit. This kit will be used for them to collect stool sample from the participating child before they come to the first and second appointments with the researcher.
The child will watch a short 2-minute video of a medium stressful scenario followed by a fun video. The child will watch the short video while the researchers evaluate the child's interest through their eye movement with an eye tracker on the computer. The child's heart rate will be measured using a Fingertip Pulse Oximeter.
During the first visit with the researcher, the parent will also receive a coupon and instructions to purchase Garden of Life Children's probiotics at the grocery store if they want their child to incorporate the probiotics in their diet for 4 weeks. They will receive instructions for the child to eat more fruits and vegetables after consulting with the child's pediatrician and/or specialist. The parent can have the researcher's recommended children's probiotics, multivitamins, more fruits and vegetables in the child's diet for 4 weeks before returning to the lab for a second observation. The child will again provide spit and stool after the 4 weeks which will be brought back to the lab during the second appointment.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Treatment | Experimental | Dietary Supplement: ProbioticPediatric Probiotic Treatment |
| No Probiotic Treatment | No intervention | –No intervention |
Who may qualify
- Ages
- 4 years to 95 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children diagnosed with Autism
- Children with neurotypical development
- Children in foster care
- Children in homeless shelters
- Children 4-7 years old
Key exclusion criteria (3 listed)
- Children younger than 4, and older than 7.9 years old.
- Inability to watch a screen
- severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticConsumption of probiotic with parent- as tolerated for 4 weeks. | Dietary supplement | Probiotic Treatment |
Primary outcome
Enteric Microbiome abundance
Time frame: 4 weeks
Increase in gut microbiome abundance (from stool samples) based on values from statistical methods, Analysis of Variance to compare differential abundance analysis.
Enteric Microbiome diversity
Time frame: 4 weeks
Increase in gut microbiome diversity in the number of beneficial bacteria in the gut (from stool samples) as measured by α-diversity measures using plot_anova_diversity function in microbiomeSeq package.
2 secondary outcomes
Improved response to stressor
Time frame: 4 weeks
Improved physiological response to stressor
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. Data will be shared based on institutional and IRB approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gesulla Cavanaugh, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Autism Spectrum Disorder and Adverse Childhood Experiences, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteric Microbiome abundance (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.