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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 30, 2021
Sponsor:
Collaborator:
Ventura Clinical Trials
Information provided by (Responsible Party):
ProgenaBiome

Tracking Information
First Submitted Date  ICMJE November 11, 2020
First Posted Date  ICMJE November 16, 2020
Last Update Posted Date April 30, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • Adverse Events [ Time Frame: 52 Weeks ]
    Number of participants with grade III or higher adverse events
  • Serious Adverse Events [ Time Frame: 52 Weeks ]
    Number of participants with serous adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • Adverse Events [ Time Frame: 52 Weeks ]
    Presence or absence of grade III or higher adverse events
  • Serious Adverse Events [ Time Frame: 52 Weeks ]
    Presence of absence of serous adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • ATEC [ Time Frame: 52 Weeks ]
    Number of participants with changes in the Autism Treatment Evaluation Checklist scores
  • CARS-2 [ Time Frame: 52 Weeks ]
    Number of participants with changes in Childhood Autism Rating Scale 2 scores
  • QoLA [ Time Frame: 52 Weeks ]
    Number of participants with changes in Quality of Life Autism scores
  • SRS-II [ Time Frame: 52 Weeks ]
    Number of participants with changes in Social Responsiveness Scale scores
  • Shannon Diversity Index [ Time Frame: 52 Weeks ]
    Changes in Shannon Diversity index compared between pre and post FMT scores
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • ATEC [ Time Frame: 52 Weeks ]
    Changes in the Autism Treatment Evaluation Checklist scores
  • CARS-2 [ Time Frame: 52 Weeks ]
    Changes in Childhood Autism Rating Scale 2 scores
  • QoLA [ Time Frame: 52 Weeks ]
    Changes in Quality of Life Autism scores
  • SRS-II [ Time Frame: 52 Weeks ]
    Changes in Social Responsiveness Scale scores
  • Shannon Diversity Index [ Time Frame: 52 Weeks ]
    Comparison of donor to recipient pre- and post-FMT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
Official Title  ICMJE 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Autism Spectrum Disorder
Intervention  ICMJE Biological: Fecal Microbiota Transplant
FMT utilizing stool from first degree relatives
Study Arms  ICMJE Experimental: Autism Subjects
These subjects will be administered fecal microbiota transplant by colonoscopy
Intervention: Biological: Fecal Microbiota Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 11, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04630847
Other Study ID Numbers  ICMJE VCT-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ProgenaBiome
Study Sponsor  ICMJE ProgenaBiome
Collaborators  ICMJE Ventura Clinical Trials
Investigators  ICMJE
Study Director: Sabine Hazan, MD ProgenaBiome
PRS Account ProgenaBiome
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP