Autism Spectrum Disorder
Conditions
Brief summary
This is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.
Detailed description
SunGenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. Customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. This is effectively an open-label study.
Interventions
DIETARY_SUPPLEMENTFlore
personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
Sponsors
Arizona State University
Sun Genomics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota
Eligibility
Sex/Gender
ALL
Age
30 Months to 75 Years
Healthy volunteers
No
Inclusion criteria
1. New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment) 2. Diagnosis of ASD (initially based on self-report of ASD diagnosis by appropriate medical professional, and then verified by an evaluation of the Social Responsiveness Scale (SRS-2) by ASU staff. 3. Children and adults ages 2.5-75 years
Exclusion criteria
1. Antibiotic use in the last two months (not counting topical antibiotics) 2. Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent Global Impressions of Autism - Change | change in score between baseline and 3 months | The PGIA-Change assesses the change in 20 different autism-related symptoms on a 7-point scale, from -3 (much worse) to 0 (no change) to +3 (much better) Note that this is a different scale than the PGIA-Baseline, which assesses severity on an absolute scale. The rationale for the two scales is that, based on our clinical experience, it appears that parents can give an approximate value for their child's severity (PGIA-Baseline), but that it is more accurate to ask them about change (with the PGIA-Change) than to ask them about severity again and compare it vs a baseline score (PGIA-Baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Responsiveness Scale | change in score between baseline and 3 months | A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems. |
| Gastrointestinal Symptom Rating Scale | change in score between baseline and 3 months | A questionnaire which evaluates 15 gastrointestinal symptoms on a severity scale from 1 (none) to 7 (severe). We report the average score of those 15 items |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 10.4 years STANDARD_DEVIATION 7.1 |
| Gastrointestinal Symptom Rating Scale (GSRS) | 2.25 units on a scale STANDARD_DEVIATION 0.97 |
| Parent Global Impressions of Autism (PGIA) - Baseline | 2.81 units on a scale STANDARD_DEVIATION 0.87 |
| Region of Enrollment United States | 296 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 236 Participants |
| Social Responsiveness Scale (SRS-2) | 80.1 units on a scale STANDARD_DEVIATION 10.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 296 |
| other Total, other adverse events | 1 / 296 |
| serious Total, serious adverse events | 0 / 296 |
Outcome results
None listed