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

Primary Purpose

Autism, Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplant
Sponsored by
ProgenaBiome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ProgenaBiome

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autism Subjects

Arm Description

These subjects will be administered fecal microbiota transplant by colonoscopy

Outcomes

Primary Outcome Measures

Adverse Events
Number of participants with grade III or higher adverse events
Serious Adverse Events
Number of participants with serous adverse events

Secondary Outcome Measures

ATEC
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
CARS-2
Number of participants with changes in Childhood Autism Rating Scale 2 scores
QoLA
Number of participants with changes in Quality of Life Autism scores
SRS-II
Number of participants with changes in Social Responsiveness Scale scores
Shannon Diversity Index
Changes in Shannon Diversity index compared between pre and post FMT scores

Full Information

First Posted
November 11, 2020
Last Updated
February 24, 2022
Sponsor
ProgenaBiome
Collaborators
Ventura Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT04630847
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProgenaBiome
Collaborators
Ventura Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autism Subjects
Arm Type
Experimental
Arm Description
These subjects will be administered fecal microbiota transplant by colonoscopy
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant
Intervention Description
FMT utilizing stool from first degree relatives
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants with grade III or higher adverse events
Time Frame
52 Weeks
Title
Serious Adverse Events
Description
Number of participants with serous adverse events
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
ATEC
Description
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
Time Frame
52 Weeks
Title
CARS-2
Description
Number of participants with changes in Childhood Autism Rating Scale 2 scores
Time Frame
52 Weeks
Title
QoLA
Description
Number of participants with changes in Quality of Life Autism scores
Time Frame
52 Weeks
Title
SRS-II
Description
Number of participants with changes in Social Responsiveness Scale scores
Time Frame
52 Weeks
Title
Shannon Diversity Index
Description
Changes in Shannon Diversity index compared between pre and post FMT scores
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject at least two years of age. Subject has confirmed diagnosis of ASD based on the DSM-V. Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process. A reliable parent or caregiver who can report the side effects and communicate effectively with the research team. Stable medications during the two months prior to enrollment. Currently receiving interventions in the community or school for ASD. 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: Female subjects who are pregnant, nursing, or intend to become pregnant during the study period. Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements. Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder. Other serious co-morbid medical disorders affecting brain function and behaviour, including uncontrolled seizures. Subjects unable to refrain from taking non-study antibiotics for the period of the study. Subjects diagnosed with cancer, except small localized basal cell carcinoma. Subjects known to abuse alcohol or drugs. Subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures. Infection with HIV. Infection with Hepatitis B or C. Hepatic values greater than 20 Allergy to benzodiazepine. Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study Known positive stool cultures for enteropathogens including, but not limited to Shigella, Salmonella, and Campylobacter within 30 days before enrollment. Known stool studies positive for ova and/or parasites in 30 days prior to enrollment. Planned travel outside United States during study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Hazan, MD
Phone
18053390549
Email
drsabinehazan@progenabiome.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Daniels, MS
Phone
18053390549
Email
jordan@progenabiome.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Organizational Affiliation
ProgenaBiome
Official's Role
Study Director
Facility Information:
Facility Name
ProgenaBiome
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD
Phone
805-339-0549
Email
drsabinehazan@progenabiome.com
First Name & Middle Initial & Last Name & Degree
Jordan Daniels, MS
Phone
805-339-0549
Email
jordan@progenabiome.com
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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