Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ventura Clinical Trials | UNKNOWN |
| Microbiome Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays.
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Subjects | Experimental | These subjects will be administered fecal microbiota transplant by colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant | Biological | FMT utilizing stool from first degree relatives |
|
| Measure | Description | Time Frame |
|---|---|---|
| ATEC | Number of participants with changes in the Autism Treatment Evaluation Checklist scores | 52 Weeks |
| QoLA | Number of participants with changes in Quality of Life Autism scores | 52 Weeks |
| CARS-2 | Number of participants with changes in Childhood Autism Rating Scale 2 scores | 52 Weeks |
| SRS-2 | Number of patients with changes in SRS-2 scores | 52 weeks |
| Behavioral changes | Changes in reported incidence of disturbances in non-core aspects of behavior or function | 52 weeks |
| GSRS | Number of patients with reported changes in GSRS measure of GI disturbances | 52 weeks |
| abbrvCDAI | Number of patients with changes in abbrevCDAI scores | 52 weeks |
| HSPP | Number of subjects with changes in quality of life metric HSPP | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Shannon Diversity Index | Changes in Shannon Diversity index compared between pre and post FMT scores | 52 Weeks |
| Microbiome changes | Number of subjects with changes to microbiome relative abundance and composition |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with grade III or higher adverse events | 52 Weeks |
| Serious Adverse Events | Number of participants with serous adverse events |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Hazan, MD | Contact | 18053390549 | drhazan@progenabiome.com | |
| Jordan Daniels, MS | Contact | 18053390549 | jordan@progenabiome.com |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Hazan, MD | ProgenaBiome | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProgenaBiome | Ventura | California | 93003 | United States |
HIPAA
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 52 weeks |
| 52 Weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |