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| Name | Class |
|---|---|
| Sun Genomics | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Each participant receives a customized probiotic based on the results of the test of their microbiota |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flore | Dietary Supplement | personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parent Global Impressions of Autism - Change | 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). | change in score between baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Social Responsiveness Scale | 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. | change in score between baseline and 3 months |
| Gastrointestinal Symptom Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Tempe | Arizona | 85287 | United States |
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| Label | URL |
|---|---|
| link to official study ad | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Each participant receives a customized probiotic based on the results of the test of their microbiota Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Each participant receives a customized probiotic based on the results of the test of their microbiota Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parent Global Impressions of Autism - Change | 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). | Posted | Mean | Standard Deviation | score on a scale | change in score between baseline and 3 months |
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During the 3 months of synbiotic treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Each participant receives a customized probiotic based on the results of the test of their microbiota Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gut symptoms, autism symptoms and behavior | General disorders | Non-systematic Assessment | participant had a worsening of their gut symptoms, autism symptoms, and behavior |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. James Adams | Arizona State University | 480 965 3316 | jim.adams@asu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2025 | Jul 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2025 | Aug 18, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C007145 | crataegus extract |
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Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota
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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 |
| change in score between baseline and 3 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Parent Global Impressions of Autism (PGIA) - Baseline | The PGIA-Baseline assesses 20 different autism-related symptoms on a 7-point scale: 0 -None 1- Slight 2 - Mild 3 - Moderate 4 - Moderately Severe 5 - Severe 6 - Extremely Severe The Average of those 20 items is reported. | Mean | Standard Deviation | units on a scale |
|
| Social Responsiveness Scale (SRS-2) | 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. (This is the raw score). | Mean | Standard Deviation | units on a scale |
|
| Gastrointestinal Symptom Rating Scale (GSRS) | 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 | Mean | Standard Deviation | units on a scale |
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| Secondary | Social Responsiveness Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | change in score between baseline and 3 months |
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| Secondary | Gastrointestinal Symptom Rating Scale | 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 | Posted | Mean | Standard Deviation | score on a scale | change in score between baseline and 3 months |
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