Clinical trial NCT04630847: Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
Official title: An Open-Label Phase I Trial of Vancomycin Followed by Familial Fecal Microbiota Transplant in Minor and Adult Subjects With Autism Spectrum Disorder (ASD) for Treatment of Social Deficits and Language Delays.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Autism
Autism Spectrum Disorder
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
Collaborators: name: Ventura Clinical Trials
First posted: 2020-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 minor and 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 minor and adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy

Eligibility criteria: Inclusion Criteria:

1. Subject at least two 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. Stable medications during the two months prior to enrollment.
6. Currently receiving interventions in the community or school for ASD.
7. 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.

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 behaviour, 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. Hepatic values greater than 20
12. Allergy to benzodiazepine.
13. Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study
14. Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study
15. Known positive stool cultures for enteropathogens including, but not limited to Shigella, Salmonella, and Campylobacter within 30 days before enrollment.
16. Known stool studies positive for ova and/or parasites in 30 days prior to enrollment.
17. Planned travel outside United States during study period.

Primary outcomes:
measure: Adverse Events
timeFrame: 52 Weeks
measure: Serious Adverse Events
timeFrame: 52 Weeks
Secondary outcomes:
measure: ATEC
timeFrame: 52 Weeks
measure: CARS-2
timeFrame: 52 Weeks
measure: QoLA
timeFrame: 52 Weeks
measure: SRS-II
timeFrame: 52 Weeks
measure: Shannon Diversity Index
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: STUDY_DIRECTOR
References: