vancomycin, Miralax, intestinal microbiota for Gastrointestinal Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Gastrointestinal Disorder+10 More
vancomycin, Miralax, intestinal microbiota - CombinationProduct
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Gastrointestinal Disorder
  • Autism Spectrum Disorders
  • Dyschezia
  • Diarrhea
  • Autism Spectrum Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gastrointestinal Disorder

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)]

Week 14
Daily Stool Record
Week 14
Aberrant Behavior Checklist
Childhood Autism Rating Scale (CARS)
Gastrointestinal Symptom Severity Scale (GSRS)
Social Responsiveness Scale 2

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Gastrointestinal Disorder

Trial Design

2 Treatment Groups

Group A - Treatment Group
1 of 2
Group B - Control Group (Miralax only for 1 day)
1 of 2
Experimental Treatment
Non-Treatment Group

70 Total Participants · 2 Treatment Groups

Primary Treatment: vancomycin, Miralax, intestinal microbiota · Has Placebo Group · Phase 2

Group A - Treatment Group
CombinationProduct
Experimental Group · 1 Intervention: vancomycin, Miralax, intestinal microbiota · Intervention Types: CombinationProduct
Group B - Control Group (Miralax only for 1 day)
CombinationProduct
PlaceboComparator Group · 1 Intervention: placebo vancomycin, Miralax, placebo intestinal microbiota · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)]

Who is running the clinical trial?

University of MinnesotaOTHER
1,239 Previous Clinical Trials
1,460,608 Total Patients Enrolled
Arizona State UniversityLead Sponsor
238 Previous Clinical Trials
89,056 Total Patients Enrolled
1 Trials studying Gastrointestinal Disorder
55 Patients Enrolled for Gastrointestinal Disorder
Arizona State University FoundationUNKNOWN
Finch TherapeuticsUNKNOWN
James B Adams, PhDPrincipal InvestigatorArizona State University
4 Previous Clinical Trials
139 Total Patients Enrolled
1 Trials studying Gastrointestinal Disorder
55 Patients Enrolled for Gastrointestinal Disorder

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The individual has not made any changes to their medications, supplements, diet, therapies, or education in the last 3 months and they do not plan on doing so during the clinical trial.
Inclusion criteria for children with ASD includes their ability to attend regular education classes with non-disabled children with accommodations and support as needed
The researchers used the Childhood Autism Rating Scale 2 (CARS-2) to diagnose autism in the participants, and they also used either the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule 2 (ADOS 2) to confirm the diagnosis.
GI disorder means a problem with the function of the digestive system that has been present for at least 3 years.
The ability to swallow pills without chewing is an important life skill.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.