A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder; Autistic Disorder; Autism; Autism, Akinetic; Autism; Atypical; Autism; Psychopathy; Autism Fragile Syndrome X; Autism With High Cognitive Abilities; Autism-Related Speech Delay; Autism, Susceptibility to, 6; Autism Spectrum Disorder High-Functioning; Autistic Thinking; Autism, Susceptibility to, X-Linked 6; Autistic Behavior
• Intervention / Treatment: Other: No Intervention

Detailed Description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding autism.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • ProgenaBiome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals ages 6 and older who have been diagnosed with Autism

Description

Inclusion Criteria:

1. Signed informed consent by parent or legally authorized representative
2. Male or female patients age 6 and older.
3. Diagnosis of autism per DSM-V criteria (See appendix)

Exclusion Criteria:

1. Refusal by parent or legally authorized representative to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of parent or legally authorized representative to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with Autism; Individuals who have been diagnosed with autism	Other: No Intervention; There is no intervention for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing	Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific Autism Spectrum Disorders	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of Sequencing Methods	To validate the methods used to sequence samples	1 year

Collaborators and Investigators

• Sponsor: ProgenaBiome
• Investigators: Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Congenital Abnormalities; Neurodevelopmental Disorders; Heredodegenerative Disorders, Nervous System; Mental Retardation, X-Linked; Intellectual Disability; Genetic Diseases, X-Linked; Sex Chromosome Disorders; Chromosome Disorders; Communication Disorders; Language Disorders; Autism Spectrum Disorder; Autistic Disorder; Fragile X Syndrome; Child Development Disorders, Pervasive; Language Development Disorders; Disease Susceptibility; Akinetic Mutism
• Other Study ID Numbers: PRG-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only aggregated and deidentified data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No