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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (0-30 days prior to treatment) vs day 14, 28,56,84 and 104

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.