Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04630847
• Other study ID #: VCT-1
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2022
• Source: ProgenaBiome
• Contact: Sabine Hazan, MD
• Phone: 18053390549
• Email: drsabinehazan[@]progenabiome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Biological:
• Fecal Microbiota Transplant
FMT utilizing stool from first degree relatives

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
ProgenaBiome	Ventura Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants with grade III or higher adverse events	52 Weeks
Primary	Serious Adverse Events	Number of participants with serous adverse events	52 Weeks
Secondary	ATEC	Number of participants with changes in the Autism Treatment Evaluation Checklist scores	52 Weeks
Secondary	CARS-2	Number of participants with changes in Childhood Autism Rating Scale 2 scores	52 Weeks
Secondary	QoLA	Number of participants with changes in Quality of Life Autism scores	52 Weeks
Secondary	SRS-II	Number of participants with changes in Social Responsiveness Scale scores	52 Weeks
Secondary	Shannon Diversity Index	Changes in Shannon Diversity index compared between pre and post FMT scores	52 Weeks