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Microbiota Therapy

Microbiota Transfer Therapy for Autism and Gastrointestinal Disorders

Phase 2
Waitlist Available
Research Sponsored by Gut-Brain-Axis Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child aged 4 to < 18 years with a diagnosis of autism per CARS-2 and either ADI-R or ADOS 2
GI disorder lasting for at least 1 year
Must not have
Single-gene disorder or major brain malformation
Males who are sexually active without highly effective birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0-30 days prior to treatment) vs day 14, 28,56,84 and 104
Awards & highlights

Summary

This trial aims to study a treatment called Microbiota Transfer Therapy (MTT) for individuals with Autism-spectrum disorder who also have gastrointestinal issues like constipation, diarrhea, or abdominal pain. M

Who is the study for?
This trial is for children with Autism Spectrum Disorder who also have gastrointestinal issues like constipation, diarrhea, or abdominal pain. Participants must meet specific criteria that the study outlines.
What is being tested?
The study tests Microbiota Transfer Therapy (MTT), which includes a 14-day vancomycin course to remove harmful bacteria, a day of bowel cleanse with Miralax, then high dose MTP-101P with an antacid for five days followed by a maintenance dose for 12 weeks.
What are the potential side effects?
Possible side effects may include digestive disturbances due to vancomycin and Miralax use. The microbiota treatment MTP-101P could cause changes in gut flora leading to bloating, gas or altered bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child, aged 4-17, is diagnosed with autism.
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I have had a gastrointestinal disorder for at least 1 year.
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I've tried at least two standard GI treatments without relief.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a single-gene disorder or a significant brain malformation.
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I am a sexually active male not using strong birth control.
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I am on tube feeding or have severe gut issues needing urgent care.
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I am severely underweight or in poor health.
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My seizure disorder does not improve with treatment, or I have health conditions that increase my risk of side effects.
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I am not pregnant and use effective birth control.
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My kidney function is significantly reduced.
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My immune system is significantly weakened.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0-30 days prior to treatment) vs day 14, 28,56,84 and 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0-30 days prior to treatment) vs day 14, 28,56,84 and 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Childhood Autism Rating Scale (CARS-2)
Daily Stool Record (DSR)
Secondary study objectives
Aberrant Behaviour Checklist (ABC-2)
CAAAS (subscale on GI symptoms)
Clinical Global Impression - Autism (CGI-A)
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group B: Treatment (Dose 2)Experimental Treatment4 Interventions
Part 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P
Group II: Group A: Treatment (Dose 1)Experimental Treatment4 Interventions
Part 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P
Group III: Group D: PlaceboPlacebo Group3 Interventions
Part 1: Blinded Placebo (15 weeks) Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P
Group IV: Group C: PlaceboPlacebo Group3 Interventions
Part 1: Blinded Placebo (15 weeks) Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2020
Completed Phase 4
~7920
Antacid
2021
Completed Phase 1
~20
Miralax
2018
Completed Phase 4
~90

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Who is running the clinical trial?

Gut-Brain-Axis Therapeutics Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
~40 spots leftby Jul 2025
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