Vancomycin and Fecal Microbiota Transplant in a Single Patient With Autism Spectrum Disorder

September 2, 2021 updated by: ProgenaBiome

Vancomycin and Fecal Microbiota Transplant in a Single Patient for the Treatment of Autism Spectrum Disorder

Single patient with ASD will be treated with Vancomycin followed by FMT.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

A single patient with profound ASD will be treated with Vancomycin. This will be followed by fecal microbiota transplant. The patient will be followed for one year.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Available
        • Ventura Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of Autism Spectrum Disorder
  2. Parent or Legally Authorized Representative willing and able to provide informed consent
  3. A reliable caregiver who can report side effects and communicate effectively with the research team
  4. Stable medications in the two months prior to enrollment
  5. Currently receiving interventions in the community/school for ASD
  6. If female and of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
  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. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (surgically sterilized)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProgenaBiome

Collaborators

Topelia Therpeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (ACTUAL)

May 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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