Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

NCT ID: NCT04655326

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2024-12-15

Brief Summary

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This is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.

Detailed Description

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SunGenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. Customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. This is effectively an open-label study.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Each participant receives a customized probiotic based on the results of the test of their microbiota

Group Type EXPERIMENTAL

Flore

Intervention Type BIOLOGICAL

personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals

Interventions

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Flore

personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment)
2. Diagnosis of ASD (initially based on self-report of ASD diagnosis by appropriate medical professional, and then verified by an evaluation of the Social Responsiveness Scale (SRS-2) by ASU staff.
3. Children and adults ages 2.5-75 years

Exclusion Criteria

1. Antibiotic use in the last two months (not counting topical antibiotics)
2. Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.
Minimum Eligible Age

30 Months

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Genomics

UNKNOWN

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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James B Adams

President's Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arizona State University

Tempe, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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STUDY00012299

Identifier Type: -

Identifier Source: org_study_id

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