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

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ClinicalTrials.gov Identifier: NCT04630847
Recruitment Status : Not yet recruiting
First Posted : November 16, 2020
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Ventura Clinical Trials
Information provided by (Responsible Party):
ProgenaBiome

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.

Condition or disease Intervention/treatment Phase
Autism Autism Spectrum Disorder Biological: Fecal Microbiota Transplant Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autism Subjects
These subjects will be administered fecal microbiota transplant by colonoscopy
Biological: Fecal Microbiota Transplant
FMT utilizing stool from first degree relatives




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 52 Weeks ]
    Number of participants with grade III or higher adverse events

  2. Serious Adverse Events [ Time Frame: 52 Weeks ]
    Number of participants with serous adverse events


Secondary Outcome Measures :
  1. ATEC [ Time Frame: 52 Weeks ]
    Number of participants with changes in the Autism Treatment Evaluation Checklist scores

  2. CARS-2 [ Time Frame: 52 Weeks ]
    Number of participants with changes in Childhood Autism Rating Scale 2 scores

  3. QoLA [ Time Frame: 52 Weeks ]
    Number of participants with changes in Quality of Life Autism scores

  4. SRS-II [ Time Frame: 52 Weeks ]
    Number of participants with changes in Social Responsiveness Scale scores

  5. Shannon Diversity Index [ Time Frame: 52 Weeks ]
    Changes in Shannon Diversity index compared between pre and post FMT scores



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04630847


Contacts
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Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com

Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Ventura Clinical Trials
Investigators
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Study Director: Sabine Hazan, MD ProgenaBiome
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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04630847    
Other Study ID Numbers: VCT-001
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders