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Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Flore

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

30 Months - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment)
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.
Children and adults ages 2.5-75 years

Exclusion Criteria:

Antibiotic use in the last two months (not counting topical antibiotics)
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.

Sites / Locations

Arizona State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

Parent Global Impressions of Autism

questionnaire which assesses 20 different autism-related symptoms on a 7-point scale

Secondary Outcome Measures

Social Responsiveness Scale

A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems.

Gastrointestinal Symptom Rating Scale

A questionnaire which evaluates 15 gastrointestinal symptoms on a severity scale from 1 (none) to 7 (severe)

Full Information

NCT ID

NCT04655326

First Posted

November 30, 2020

Last Updated

January 6, 2023

Sponsor

Arizona State University

Collaborators

Sun Genomics

1. Study Identification

Unique Protocol Identification Number

NCT04655326

Brief Title

Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Official Title

Assessment of Customized Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Arizona State University

Collaborators

Sun Genomics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Flore

Intervention Description

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

Primary Outcome Measure Information:

Title

Parent Global Impressions of Autism

Description

questionnaire which assesses 20 different autism-related symptoms on a 7-point scale

Time Frame

change in score between baseline and 3 months

Secondary Outcome Measure Information:

Title

Social Responsiveness Scale

Description

A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems.

Time Frame

change in score between baseline and 3 months

Title

Gastrointestinal Symptom Rating Scale

Description

A questionnaire which evaluates 15 gastrointestinal symptoms on a severity scale from 1 (none) to 7 (severe)

Time Frame

change in score between baseline and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Months

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment) 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. Children and adults ages 2.5-75 years Exclusion Criteria: Antibiotic use in the last two months (not counting topical antibiotics) 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James B. Adams, PhD

Phone

480 965 3316

jim.adams@asu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Devon Coleman, BS

Phone

480 965 5071

devon.coleman@asu.edu

Facility Information:

Facility Name

Arizona State University

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James B Adams, PhD

Phone

480-965-3316

jim.adams@asu.edu

First Name & Middle Initial & Last Name & Degree

Devon Coleman, BS

Phone

480 965 5071

devon.coleman@asu.edu

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://autism.asu.edu/research-studies

Description

link to official study ad

Learn more about this trial

Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

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