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

• Conditions: Autism, Akinetic; Autism, Susceptibility to, X-Linked 6; Autism; Psychopathy; Autism, Susceptibility to, 6; Autism Spectrum Disorder High-Functioning; Autism; Autism Spectrum Disorder; Autism Fragile Syndrome X; Autism With High Cognitive Abilities; Autism-Related Speech Delay
• Interventions: Other: No Intervention

• Registration Number: NCT04100863
• Lead Sponsor: ProgenaBiome

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Study Start: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-03
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with Autism	No Intervention	Individuals who have been diagnosed with autism

Primary Outcome Measures

Name	Time	Method
Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing	1 year	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

Secondary Outcome Measures

Name	Time	Method
Validation of Sequencing Methods	1 year	To validate the methods used to sequence samples

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States