What side effects are associated with this type of intervention?

The most common treatments for Autism Spectrum Disorder (ASD) that involve gut microbiota modification, such as Familial Fecal Microbiota Transplant (FMT), probiotics, and prebiotics, generally have a good safety profile. However, potential side effects include gastrointestinal symptoms like abdominal discomfort, bloating, gas, and diarrhea. In rare cases, there may be a risk of infection or adverse immune responses. It is important for patients to discuss these treatments with their healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting the restoration of healthy gut microbiota for Autism Spectrum Disorder (ASD) similar to the Familial Fecal Microbiota Transplant (FMT) being studied. The FDA has approved medications like risperidone and aripiprazole for the treatment of irritability associated with ASD, but these do not address gut microbiota. Research into gut microbiota and its potential impact on ASD symptoms is ongoing, and treatments like FMT are still under clinical investigation.

What other types of research exist?

Promising, novel alternatives to Familial Fecal Microbiota Transplant for Autism Spectrum Disorder patients include the use of probiotics, prebiotics, and synbiotics. These therapies aim to modulate the gut microbiota and improve gastrointestinal and possibly behavioral symptoms associated with ASD. Specific strains of probiotics, such as Lactobacillus and Bifidobacterium, have been studied for their potential benefits. Additionally, ongoing research into the gut-brain axis may yield new therapeutic approaches targeting gut health to influence neurological outcomes.

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Fecal Microbiota Transplant

Fecal Microbiota Transplant for Autism

Phase 1

Waitlist Available

Research Sponsored by ProgenaBiome

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently receiving interventions in the community or school for ASD

Currently receiving interventions in the community or school for ASD.

Must not have

Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study

Female subjects who are pregnant, nursing, or intend to become pregnant during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment for people with Autism Spectrum Disorder that involves taking an antibiotic for a period of time followed by a procedure involving gut health from a family member. The goal is to improve social skills and language by enhancing gut health.

Who is the study for?

This trial is for individuals at least two years old with a confirmed diagnosis of Autism Spectrum Disorder (ASD) who are stable on medications and receiving community or school interventions. Participants need a reliable caregiver to report side effects. Males with partners of childbearing potential must use birth control. Exclusions include pregnancy, nursing, unwilling caregivers, certain medical conditions like uncontrolled seizures, substance abuse, major surgeries like gastric bypass or total colectomy planned or done.

What is being tested?

The study tests the effect of fecal microbiota transplant from family members in treating social deficits and language delays in ASD patients after a preliminary treatment with Vancomycin for six weeks. It's an open-label trial where everyone knows what treatment is being given.

What are the potential side effects?

Potential side effects may include digestive discomforts such as bloating and diarrhea due to the nature of fecal transplants and antibiotics involved. The full range of side effects will be monitored by caregivers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am getting help for autism at school or in the community.

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I am getting help for autism at school or in the community.

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I am at least two years old.

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I have been diagnosed with Autism Spectrum Disorder.

Exclusion Criteria

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

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I cannot stop taking my diarrhea medication before the study.

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I am not pregnant, nursing, or planning to become pregnant during the study.

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I do not have any serious health issues affecting my brain function, like uncontrolled seizures.

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I have been diagnosed with cancer, but it's not a small, localized basal cell carcinoma.

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I cannot stop taking antibiotics not part of the study during the trial.

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I have had, or will have, surgery to remove my stomach or entire colon.

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I am HIV positive.

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I have Hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events

Serious Adverse Events

Secondary study objectives

ATEC

CARS-2

QoLA

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Autism SubjectsExperimental Treatment1 Intervention

These subjects will be administered fecal microbiota transplant by colonoscopy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplant

2021

Completed Phase 4

~190

0 / 12Eligibility 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

Familial fecal microbiota transplant (FMT) aims to restore healthy gut microbiota by transferring stool from a healthy donor to the gastrointestinal tract of an ASD patient. This treatment is preceded by a 6-week course of Vancomycin, an antibiotic that reduces harmful bacteria in the gut. The rationale behind this approach is that gut microbiota play a crucial role in modulating the immune system and neurodevelopment, which are often dysregulated in ASD. By restoring a healthy balance of gut bacteria, FMT may improve gastrointestinal symptoms and potentially alleviate some behavioral and social deficits associated with ASD. This matters for ASD patients as it offers a novel therapeutic avenue that targets the gut-brain axis, potentially leading to improvements in both physical and neuropsychiatric symptoms.