Fecal Microbiota Transplant for Autism, Early Infantile

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism, Early Infantile+4 More
Fecal Microbiota Transplant - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether fecal microbiota transplantation, following treatment with Vancomycin, can help improve social deficits and language delays in people with ASD.

Eligible Conditions
  • Autism, Early Infantile
  • Autism Spectrum Disorders
  • Autism Spectrum Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 52 Weeks

52 Weeks
ATEC
Adverse Events
CARS-2
QoLA
SRS-II
Serious Adverse Events
Shannon Diversity Index

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Autism Subjects
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Fecal Microbiota Transplant · No Placebo Group · Phase 1

Autism Subjects
Biological
Experimental Group · 1 Intervention: Fecal Microbiota Transplant · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant
2014
Completed Phase 3
~160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks

Who is running the clinical trial?

ProgenaBiomeLead Sponsor
44 Previous Clinical Trials
5,782 Total Patients Enrolled
2 Trials studying Autism, Early Infantile
100 Patients Enrolled for Autism, Early Infantile
Ventura Clinical TrialsUNKNOWN
Sabine Hazan, MDStudy DirectorProgenaBiome
40 Previous Clinical Trials
5,481 Total Patients Enrolled
2 Trials studying Autism, Early Infantile
100 Patients Enrolled for Autism, Early Infantile

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least two years of age.\n
You are of childbearing potential and you are willing to use at least one highly effective method of birth control for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Maryland33.3%
Illinois33.3%
Florida33.3%
How old are they?
< 18100.0%
What site did they apply to?
ProgenaBiome100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%