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

NCT04100863 | Withdrawn DMC

• 1 other identifier: PRG-006
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism; Autism Spectrum Disorder; Autistic Disorder; 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validation of Sequencing Methods

  1 year

Study Arms (1)

Individuals with Autism

Individuals who have been diagnosed with autism

Other: No Intervention

Interventions

No Intervention OTHER

There is no intervention for this study.

Individuals with Autism

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals ages 6 and older who have been diagnosed with Autism

You may qualify if:

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

You may not qualify if:

• Refusal by parent or legally authorized representative to sign informed consent form
• Treatment with antibiotics within 2 weeks prior to screening
• Treatment with probiotics within 6 weeks prior to screening
• History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
• Postoperative stoma, ostomy, or ileoanal pouch
• Participation in any experimental drug protocol within the past 12 weeks
• Treatment with total parenteral nutrition
• Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Akinetic Mutism; Antisocial Personality Disorder; Fragile X Syndrome; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Personality Disorders; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)