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Fecal Microbiota Transplant

Fecal Microbiota Transplant for Autism

Phase 1
Waitlist Available
Research Sponsored by ProgenaBiome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently receiving interventions in the community or school for ASD
Currently receiving interventions in the community or school for ASD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

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.

Who is the study for?
This trial is for individuals at least two years old with a confirmed diagnosis of Autism Spectrum Disorder (ASD) who are stable on medications and receiving community or school interventions. Participants need a reliable caregiver to report side effects. Males with partners of childbearing potential must use birth control. Exclusions include pregnancy, nursing, unwilling caregivers, certain medical conditions like uncontrolled seizures, substance abuse, major surgeries like gastric bypass or total colectomy planned or done.Check my eligibility
What is being tested?
The study tests the effect of fecal microbiota transplant from family members in treating social deficits and language delays in ASD patients after a preliminary treatment with Vancomycin for six weeks. It's an open-label trial where everyone knows what treatment is being given.See study design
What are the potential side effects?
Potential side effects may include digestive discomforts such as bloating and diarrhea due to the nature of fecal transplants and antibiotics involved. The full range of side effects will be monitored by caregivers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am getting help for autism at school or in the community.
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I am getting help for autism at school or in the community.
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I am at least two years old.
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I have been diagnosed with Autism Spectrum Disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Serious Adverse Events
Secondary outcome measures
ATEC
CARS-2
QoLA
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autism SubjectsExperimental Treatment1 Intervention
These subjects will be administered fecal microbiota transplant by colonoscopy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant
2021
Completed Phase 4
~190

Find a Location

Who is running the clinical trial?

ProgenaBiomeLead Sponsor
44 Previous Clinical Trials
5,300 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
100 Patients Enrolled for Autism Spectrum Disorder
Ventura Clinical TrialsUNKNOWN
Sabine Hazan, MDStudy DirectorProgenaBiome
40 Previous Clinical Trials
4,999 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
100 Patients Enrolled for Autism Spectrum Disorder

Media Library

Fecal Microbiota Transplant (Fecal Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04630847 — Phase 1
Autism Spectrum Disorder Research Study Groups: Autism Subjects
Autism Spectrum Disorder Clinical Trial 2023: Fecal Microbiota Transplant Highlights & Side Effects. Trial Name: NCT04630847 — Phase 1
Fecal Microbiota Transplant (Fecal Microbiota Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630847 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Fecal Microbiota Transplant a reliable procedure with no serious risks?

"The safety of Fecal Microbiota Transplant was assessed as 1 on our scale due to the limited data in Phase 1 trials that address both its efficacy and security."

Answered by AI

Is this experiment enrolling participants at the present time?

"The latest update to clinicaltrials.gov indicates that this particular medical trial is no longer recruiting patients, as the research commenced on May 1st 2022 and was last revised on February 24th 2022. Although there are presently 278 other trials actively enrolling participants."

Answered by AI

What outcomes is this research endeavor working to realize?

"This research project, with a duration of 52 Weeks, aims to track Serious Adverse Events. Additionally, the Autism Treatment Evaluation Checklist (ATEC), Childhood Autism Rating Scale 2 (CARS-2) and Shannon Diversity Index will be monitored to measure secondary objectives."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Illinois
Florida
How old are they?
< 18
What site did they apply to?
ProgenaBiome
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have seen and researched a great deal on this. It appears to have a promising outcome for my son.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
2022. "Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04630847.
All > Asd > Autism
~10 spots leftby Jun 2025
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