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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100863
• Other study ID #: PRG-006
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: June 2023

Study information

• Verified date: September 2021
• Source: ProgenaBiome
• Contact: Sabine Hazan, MD
• Phone: 18053390549
• Email: drsabinehazan[@]progenabiome.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Akinetic Mutism
• Autism
• Autism Fragile Syndrome X
• Autism Spectrum Disorder
• Autism Spectrum Disorder High-Functioning
• Autism With High Cognitive Abilities
• Autism, Akinetic
• Autism, Susceptibility to, 6
• Autism, Susceptibility to, X-Linked 6
• Autism-Related Speech Delay
• Autism; Atypical
• Autism; Psychopathy
• Autistic Behavior
• Autistic Disorder
• Autistic Thinking
• Child Development Disorders, Pervasive
• Disease
• Disease Susceptibility
• Fragile X Syndrome
• Language Development Disorders

Intervention

Other:
• No Intervention
There is no intervention for this study.

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Validation of Sequencing Methods	To validate the methods used to sequence samples	1 year