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
Other trials for Autism, Early Infantile
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
Other trials for Autism, Early Infantile
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: BiologicalTreatment
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 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?
| Maryland | 33.3% |
| Illinois | 33.3% |
| Florida | 33.3% |
How old are they?
| < 18 | 100.0% |
What site did they apply to?
| ProgenaBiome | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments