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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.
Must not have
Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study
Female subjects who are pregnant, nursing, or intend to become pregnant during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Summary

This trial is testing a treatment for people with Autism Spectrum Disorder that involves taking an antibiotic for a period of time followed by a procedure involving gut health from a family member. The goal is to improve social skills and language by enhancing gut health.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot stop taking my diarrhea medication before the study.
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I am not pregnant, nursing, or planning to become pregnant during the study.
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I do not have any serious health issues affecting my brain function, like uncontrolled seizures.
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I have been diagnosed with cancer, but it's not a small, localized basal cell carcinoma.
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I cannot stop taking antibiotics not part of the study during the trial.
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I have had, or will have, surgery to remove my stomach or entire colon.
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I am HIV positive.
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I have Hepatitis B or C.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Serious Adverse Events
Secondary study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Familial fecal microbiota transplant (FMT) aims to restore healthy gut microbiota by transferring stool from a healthy donor to the gastrointestinal tract of an ASD patient. This treatment is preceded by a 6-week course of Vancomycin, an antibiotic that reduces harmful bacteria in the gut. The rationale behind this approach is that gut microbiota play a crucial role in modulating the immune system and neurodevelopment, which are often dysregulated in ASD. By restoring a healthy balance of gut bacteria, FMT may improve gastrointestinal symptoms and potentially alleviate some behavioral and social deficits associated with ASD. This matters for ASD patients as it offers a novel therapeutic avenue that targets the gut-brain axis, potentially leading to improvements in both physical and neuropsychiatric symptoms.

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
~6 spots leftby Jun 2025
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