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Microbiota Transfer Therapy

Microbiota Transfer Therapy for Autism Spectrum Disorder (MTT-ASD Trial)

Phase 2
Waitlist Available
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult aged 18-60 years
Diagnosis of autism per both the Autism Diagnostic Interview - Revised (ADI-R) and the Childhood Autism Rating Scale 2 (CARS-2)
Must not have
Severe gastrointestinal problems that require immediate treatment (life-threatening)
Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a therapy that has been shown to help children with ASD and GI problems will also help adults with ASD and GI problems.

Who is the study for?
Adults aged 18-60 with Autism Spectrum Disorder and long-term gastrointestinal issues, who haven't changed their treatment plans in the last 3 months. They must be able to swallow pills and have a close observer to report on their condition. Excluded are those with certain genetic disorders, recent antibiotics or probiotics use, other clinical trial participation, severe GI conditions like Crohn's Disease, or women who are pregnant without effective birth control.
What is being tested?
The trial tests Microbiota Transfer Therapy (MTT) for adults with ASD and GI problems. It involves using Vancomycin followed by MoviPrep (a bowel cleaning solution), then introducing Full Spectrum Microbiota to improve gut health and potentially reduce ASD symptoms based on previous positive results in children.
What are the potential side effects?
Possible side effects include digestive discomfort from Vancomycin and MoviPrep during the initial phases of therapy. The introduction of Full Spectrum Microbiota may cause changes in bowel habits or abdominal pain as the body adjusts to new gut bacteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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I have been diagnosed with autism based on ADI-R and CARS-2 assessments.
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I have had a gastrointestinal disorder for at least 3 years.
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I haven't changed my medications, diet, or therapies in the last 3 months and don't plan to change them during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe, life-threatening gastrointestinal issues needing immediate treatment.
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I have been diagnosed with a specific digestive condition like Ulcerative Colitis or Crohn's Disease.
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I have taken probiotics in the last 2 months or had a fecal transplant in the last year.
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I am receiving nutrition through a tube.
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I have a significant brain malformation.
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I have a genetic disorder like Fragile X.
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I am not pregnant and use effective birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Childhood Autism Rating Scale (CARS) from baseline to 10 weeks
Secondary study objectives
Change in Aberrant Behavior Checklist from baseline to 10 weeks
Change in Daily Stool Log (DSL) from baseline to 10 weeks
Change in Social Responsiveness Scale - 2 from baseline to 10 weeks of treatment
Other study objectives
Autistic Disorder
Change in Microbiome composition from baseline to 10 weeks
Change in Ohio State University Clinical Impressions Scale, from baseline 10 weeks
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
Group B receives no treatment in Part 1, but does receive treatment in Part 2
Group II: Group AExperimental Treatment3 Interventions
Group A receives treatment in Part 1 and Part 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2020
Completed Phase 4
~7920
Full Spectrum Microbiota
2017
Completed Phase 2
~210
MoviPrep
2012
Completed Phase 4
~2230

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
301 Previous Clinical Trials
107,995 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
708 Patients Enrolled for Autism Spectrum Disorder
James B Adams, PhDStudy DirectorArizona State University
4 Previous Clinical Trials
139 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
98 Patients Enrolled for Autism Spectrum Disorder

Media Library

Microbiota Transfer Therapy (Microbiota Transfer Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03408886 — Phase 2
~7 spots leftby Dec 2025
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