Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Arizona State University296 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

296

Conditions

Autism Spectrum Disorder

Interventions

FloreDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 30 MonthsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Arizona State University

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Parent Global Impressions of Autism - Change

The PGIA-Change assesses the change in 20 different autism-related symptoms on a 7-point scale, from -3 (much worse) to 0 (no change) to +3 (much better) Note that this is a different scale than the PGIA-Baseline, which assesses severity on an absolute scale. The rationale for the two scales is that, based on our clinical experience, it appears that parents can give an approximate value for their child's severity (PGIA-Baseline), but that it is more accurate to ask them about change (with the PGIA-Change) than to ask them about severity again and compare it vs a baseline score (PGIA-Baseline).

Time frame: change in score between baseline and 3 months

Secondary Outcomes

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.

Time frame: change in score between baseline and 3 months

Gastrointestinal Symptom Rating Scale

A questionnaire which evaluates 15 gastrointestinal symptoms on a severity scale from 1 (none) to 7 (severe). We report the average score of those 15 items

Time frame: change in score between baseline and 3 months

Data from ClinicalTrials.gov

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