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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)

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

MTT-ASD Trial 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.Check my eligibility

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.See study design

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.

MTT-ASD Trial 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.

MTT-ASD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Childhood Autism Rating Scale (CARS) from baseline to 10 weeks

Secondary outcome measures

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 outcome measures

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

MTT-ASD 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

2005

Completed Phase 4

~7930

MoviPrep

2012

Completed Phase 4

~1710

Full Spectrum Microbiota

2017

Completed Phase 2

~210

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor

283 Previous Clinical Trials

109,459 Total Patients Enrolled

8 Trials studying Autism Spectrum Disorder

678 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

Frequently Asked Questions

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

Who qualifies to partake in this experimental research?

"This clinical trial requires 55 adults ranging in age from 18 to 60, who have a gastrointestinal disorder and are medically stable. Patients must be able to take medications without chewing them as well as provide an evaluator (family member/guardian) who can observe the patient for 4 hours a week."

Answered by AI

Are researchers currently accepting new participants into this research endeavor?

"The clinical trial's listing on clinicaltrials.gov suggests that it is no longer recruiting patients, having first been posted on April 1st 2018 and last updated December 29 2021. However, there are still 1406 other medical studies currently looking for participants to enrol in their tests."

Answered by AI

Are there any other experiments that have explored the effects of Full Spectrum Microbiota?

"At this juncture, 218 clinical trials are actively being conducted on Full Spectrum Microbiota with 39 studies at Phase 3. Calgary, Alberta is a hub for such research but 1190 facilities across the world are also partaking in investigations into FSM."

Answered by AI

What maladies can be addressed by Full Spectrum Microbiota?

"Full Spectrum Microbiota is regularly prescribed to restore electrolyte balance and can be utilized to stabilize parenteral nutrition, regional citrate anticoagulation (RCA), as well as irritations of the skin."

Answered by AI

What potential risks are associated with the utilization of Full Spectrum Microbiota?

"As this is a Phase 2 clinical trial, the safety of Full Spectrum Microbiota was deemed to be at least satisfactory with a score of 2. Nonetheless, there is currently no evidence supporting its efficacy."

Answered by AI

Is there an upper age limit for participants of this investigation?

"This trial's parameters stipulate that the minimum age for enrollment is 18 and no one over 60 can be included."

Answered by AI

What is the recruitment capacity for this experiment?

"Sadly, this clinical trial has concluded its recruitment phase. The initial posting on January 4th 2018 was followed by an edit on December 29th 2021. Nevertheless, there are 1188 trials currently recruiting for gastrointestinal disorder and 218 studies enrolling participants with Full Spectrum Microbiota."

Answered by AI

Recent research and studies

MicrobiomeJournal

Microbiota Transfer Therapy Alters Gut Ecosystem and Improves Gastrointestinal and Autism Symptoms: An Open-label Study

Kang, Dae-Wook, James B. Adams, Ann C. Gregory, Thomas Borody, Lauren Chittick, Alessio Fasano, Alexander Khoruts, et al.. 2017. “Microbiota Transfer Therapy Alters Gut Ecosystem and Improves Gastrointestinal and Autism Symptoms: An Open-label Study”. Microbiome. Springer Science and Business Media LLC. doi:10.1186/s40168-016-0225-7.

MicrobiomeJournal

Microbiota Transfer Therapy Alters Gut Ecosystem and Improves Gastrointestinal and Autism Symptoms: An Open-label Study

clinicaltrials.govStudy

Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders

2018. "Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03408886.

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