What is the mechanism of action of this treatment?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, which work by enhancing communication, social skills, and adaptive behaviors through structured and individualized programs. These interventions often involve a high staff-to-student ratio, family involvement, and ongoing program adjustments. In terms of gut microbiota restoration, treatments like Microbiota Transfer Therapy (MTT) aim to re-establish a healthy balance of intestinal microbes, which may influence neurological and immune functions. This is significant for ASD patients as emerging research suggests a link between gut health and behavioral symptoms, potentially offering a novel approach to managing ASD symptoms.

What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that focus on restoring healthy gut microbiota include probiotics and fecal microbiota transplantation (FMT). Probiotics are generally considered safe with few side effects, but they can occasionally cause mild gastrointestinal symptoms such as gas and bloating. FMT, while showing some promise in reducing gastrointestinal symptoms in ASD, can have more significant risks including infection, allergic reactions, and, in rare cases, serious complications like sepsis. Both treatments require further research to fully understand their safety profiles and long-term effects.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting the restoration of healthy gut microbiota for Autism Spectrum Disorder (ASD). The FDA has approved medications such as risperidone and aripiprazole to address irritability associated with ASD. These medications do not focus on gut microbiota but rather on managing behavioral symptoms. Microbiota Transfer Therapy (MTT) is still under investigation and has not yet received FDA approval for the treatment of ASD.

What other types of research exist?

Promising novel alternatives to Microbiota Transfer Therapy (MTT) for Autism Spectrum Disorder (ASD) patients include the use of prebiotics and probiotics. These therapies aim to modulate the gut microbiota and have shown potential benefits in various studies. Additionally, synbiotics, which combine prebiotics and probiotics, have demonstrated efficacy in improving gastrointestinal symptoms and possibly behavioral symptoms in ASD patients. Further research and clinical trials are needed to confirm their effectiveness and safety.

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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

Must not have

Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions

Single-gene disorder (Fragile X, etc.)

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)]

Summary

This trial tests a treatment called Microbiota Transfer Therapy (MTT) for children with Autism Spectrum Disorder and gut problems. It uses antibiotics to clear bad bacteria, cleans the bowel, and then adds good bacteria from donor stool over a few months. The goal is to see if this helps improve their symptoms. Microbiota Transfer Therapy (MTT) has shown significant improvements in gastrointestinal and autism symptoms in previous studies, with benefits persisting for some time after treatment.

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.

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.

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

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I have been diagnosed with autism based on specific assessments.

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My child is between 5 and 17 years old.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a chronic inflammatory bowel condition.

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I have a genetic disorder like Fragile X.

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I am not pregnant and use effective birth control.

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I have severe, life-threatening gastrointestinal issues needing immediate treatment.

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I have a significant brain malformation.

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My immune system is weak, or I'm on medication that weakens it.

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I am receiving nutrition through a tube.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in % abnormal days from baseline (for 2 weeks) vs. week 14 (2 weeks from week 13-14)]

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Childhood Autism Rating Scale (CARS)

Gastrointestinal Symptom Severity Scale (GSRS)

Secondary study objectives

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, which work by enhancing communication, social skills, and adaptive behaviors through structured and individualized programs. These interventions often involve a high staff-to-student ratio, family involvement, and ongoing program adjustments. In terms of gut microbiota restoration, treatments like Microbiota Transfer Therapy (MTT) aim to re-establish a healthy balance of intestinal microbes, which may influence neurological and immune functions. This is significant for ASD patients as emerging research suggests a link between gut health and behavioral symptoms, potentially offering a novel approach to managing ASD symptoms.