Autism, Autism Spectrum Disorder
Conditions
Keywords
microbiome, dysbiosis, FMT, fecal transpant, fecal microbiota transplant
Brief summary
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.
Detailed description
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
Interventions
BIOLOGICALFecal Microbiota Transplant
FMT utilizing stool from first degree relatives
Sponsors
Ventura Clinical Trials
Microbiome Research Foundation
ProgenaBiome
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject at least six years of age. 2. Subject has confirmed diagnosis of ASD based on the DSM-V. 3. Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process. 4. A reliable parent or caregiver who can report the side effects and communicate effectively with the research team. 5. Comorbid gastrointestinal symptoms 6. Stable medications during the two months prior to enrollment. 7. Currently receiving interventions in the community or school for ASD. 8. If female and of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes oral birth control pills, contraceptive implants, and intra-uterine devices. Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (e.g., post-menopausal, surgically sterilized) 9. If male, and partner is of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes oral birth control pills, contraceptive implants, and intra-uterine devices Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (surgically sterilized)
Exclusion criteria
1. Female subjects who are pregnant, nursing, or intend to become pregnant during the study period. 2. Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements. 3. Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder. 4. Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures. 5. Subjects unable to refrain from taking non-study antibiotics for the period of the study. 6. Subjects diagnosed with cancer, except small localized basal cell carcinoma. 7. Subjects known to abuse alcohol or drugs. 8. Subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures. 9. Infection with HIV. 10. Infection with Hepatitis B or C. 11. Allergy to benzodiazepine. 12. Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study 13. Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study 14. Known positive stool cultures for enteropathogens including, but not limited to Shigella, Salmonella, and Campylobacter within 30 days before enrollment. (These infection agents should be treated in advance of participation in this FMT study because they affect the good flora). 15. Known stool studies positive for ova and/or parasites in 30 days prior to enrollment. (Same as above). 16. Planned travel outside United States during study period. 17. Hypersensitivity to vancomycin 18. Renal insufficiency 19. Colitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HSPP | 52 weeks | Number of subjects with changes in quality of life metric HSPP |
| SRS-2 | 52 weeks | Number of patients with changes in SRS-2 scores |
| Behavioral changes | 52 weeks | Changes in reported incidence of disturbances in non-core aspects of behavior or function |
| GSRS | 52 weeks | Number of patients with reported changes in GSRS measure of GI disturbances |
| abbrvCDAI | 52 weeks | Number of patients with changes in abbrevCDAI scores |
| ATEC | 52 Weeks | Number of participants with changes in the Autism Treatment Evaluation Checklist scores |
| QoLA | 52 Weeks | Number of participants with changes in Quality of Life Autism scores |
| CARS-2 | 52 Weeks | Number of participants with changes in Childhood Autism Rating Scale 2 scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shannon Diversity Index | 52 Weeks | Changes in Shannon Diversity index compared between pre and post FMT scores |
| Microbiome changes | 52 weeks | Number of subjects with changes to microbiome relative abundance and composition |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 52 Weeks | Number of participants with serous adverse events |
| Adverse Events | 52 Weeks | Number of participants with grade III or higher adverse events |
Countries
United States
Contacts
Primary ContactSabine Hazan, MD
Backup ContactJordan Daniels, MS
Outcome results
None listed