Menu
Not yet recruiting NCT04630847

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

Phase I Interventional Autism Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal Microbiota Transplant.
Who it may be relevant to
Registry conditions: Autism, Autism Spectrum Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label Phase I Clinical Trial of Vancomycin Followed by Familial Fecal Microbiota Transplant in Adult Subjects With Autism Spectrum Disorder (ASD)

Overview

This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in 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 adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy

Interventions

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

Primary outcome measures

  • ATEC [Time frame: 52 Weeks]
  • QoLA [Time frame: 52 Weeks]
  • CARS-2 [Time frame: 52 Weeks]
  • SRS-2 [Time frame: 52 weeks]
  • Behavioral changes [Time frame: 52 weeks]
  • GSRS [Time frame: 52 weeks]
  • abbrvCDAI [Time frame: 52 weeks]
  • HSPP [Time frame: 52 weeks]
Secondary outcome measures (2)
  • Shannon Diversity Index [Time frame: 52 Weeks]
  • Microbiome changes [Time frame: 52 weeks]

Eligibility criteria

Inclusion criteria

  • Subject at least six 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.
  • Comorbid gastrointestinal symptoms
  • Stable medications during the two months prior to enrollment.
  • Currently receiving interventions in the community or school for ASD.
  • 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 oral birth control pills, contraceptive implants, and intra-uterine devices. Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (e.g., post-menopausal, surgically sterilized)
  • 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 oral birth control pills, contraceptive implants, and intra-uterine devices Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (surgically sterilized)

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 behavior, 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.
  • 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. (These infection agents should be treated in advance of participation in this FMT study because they affect the good flora).
  • Known stool studies positive for ova and/or parasites in 30 days prior to enrollment. (Same as above).
  • Planned travel outside United States during study period.
  • Hypersensitivity to vancomycin
  • Renal insufficiency
  • Colitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • ProgenaBiome — Ventura

Identifiers

NCT: NCT04630847 · VCT-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗