← Back to Search

Intestinal Microbiota

Microbiota Transfer Therapy for Autism and Gastrointestinal Issues

Phase 2
Waitlist Available
Led By James B Adams, PhD
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of autism per the Childhood Autism Rating Scale 2 (CARS-2) and either the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule 2 (ADOS 2).
Child aged 5-17 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)]
Awards & highlights

Study Summary

This trial will study whether Microbiota Transfer Therapy is an effective treatment for children with Autism Spectrum Disorder and gastrointestinal problems.

Who is the study for?
This trial is for children aged 5-17 with Autism Spectrum Disorder and gastrointestinal issues like constipation or diarrhea. They must be able to swallow pills, have stable health aside from GI problems, and not plan any treatment changes during the study. Kids on psychotropic meds, recent antibiotics, probiotics, or those with severe GI conditions are excluded.Check my eligibility
What is being tested?
The trial tests Microbiota Transfer Therapy (MTT) in kids with ASD and GI disorders. It starts with a 10-day course of vancomycin (an antibiotic), followed by a bowel cleanse, then a 12-week Fecal Microbiota treatment. Some participants will receive placebos instead of actual treatments for comparison.See study design
What are the potential side effects?
Possible side effects include reactions to vancomycin such as rash or allergic responses; digestive issues due to Miralax like bloating or cramps; and potential risks associated with microbiota transfer including abdominal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with autism based on specific assessments.
Select...
My child is between 5 and 17 years old.
Select...
I haven't changed my medications, diet, or therapies in the last 3 months and don't plan to change them during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)]
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Childhood Autism Rating Scale (CARS)
Gastrointestinal Symptom Severity Scale (GSRS)
Secondary outcome measures
Aberrant Behavior Checklist
Daily Stool Record
Social Responsiveness Scale 2

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A - Treatment GroupExperimental Treatment1 Intervention
This group will receive vancomycin for 14 days, then Miralax for 1 day, then intestinal microbiota for 2 days at high dose, then intestinal microbiota for 12 weeks at a maintenance dose
Group II: Group B - Control Group (Miralax only for 1 day)Placebo Group1 Intervention
This group will receive placebo vancomycin for 14 days, then Miralax for 1 day, then placebo intestinal microbiota for 2 days at high dose, then placebo intestinal microbiota for 12 weeks at a maintenance dose

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
285 Previous Clinical Trials
109,493 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
683 Patients Enrolled for Autism Spectrum Disorder
University of MinnesotaOTHER
1,387 Previous Clinical Trials
1,552,442 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
126 Patients Enrolled for Autism Spectrum Disorder
Finch TherapeuticsUNKNOWN

Media Library

Autism Spectrum Disorder Research Study Groups: Group A - Treatment Group, Group B - Control Group (Miralax only for 1 day)

Frequently Asked Questions

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

In what manner are vancomycin, Miralax, and intestinal microbiota commonly deployed?

"Vancomycin, Miralax and intestinal microbiota are routinely used to treat colonoscopy. Additionally, they can help patients who suffer from clostridium difficile associated diarrhea (CDAD), staphylococcal infections, or need bowel preparation therapy."

Answered by AI

Could you provide a synopsis of previous experiments conducted concerning vancomycin, Miralax, and intestinal microbiota?

"Presently, there are 69 active trials for vancomycin, Miralax and intestinal microbiota with 6 of those studies in Phase 3. Location wise, Cleveland Ohio is a major hub but the research spans over 338 sites globally."

Answered by AI

Is this research open to geriatric participants?

"As per the conditions of this study, the minimum age for enrolment is 5 years old and the maximum permitted age is 17."

Answered by AI

How many participants are being sought for this research project?

"Affirmative. According to clinicaltrials.gov, the trial - first posted on November 15th 2019 - is now actively searching for participants. 70 individuals are required from one medical facility."

Answered by AI

Are there any potential risks associated with the ingestion of vancomycin, Miralax and intestinal microbiota?

"The safety of vancomycin, Miralax, and intestinal microbiota was assessed at a level of 2. This is because this Phase 2 trial has collected evidence supporting its safety yet no proof of efficacy."

Answered by AI

Are there any open spaces in this clinical trial?

"The data hosted on clinicaltrials.gov verifies that this medical trial is seeking volunteers; the study was first posted in November 15th 2019 and recently revised December 29th 2021."

Answered by AI

Am I eligible to participate in the current research program?

"This research is recruiting 70 minors aged between 5-17 with gastrointestinal issues. To be eligible, candidates must not have changed any medication, supplement, diet or therapy in the past 3 months and should not intend to do so throughout the trial. Additionally, they need to be able to swallow pills without chewing them and present a general good health aside from their GI symptoms."

Answered by AI
~9 spots leftby May 2025