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

ProgenaBiome

Status

Withdrawn

Conditions

Autism, Akinetic

Autistic Behavior

Autism Spectrum Disorder

Autism, Susceptibility to, X-Linked 6

Autism

Autistic Thinking

Autistic Disorder

Autism, Susceptibility to, 6

Autism; Psychopathy

Autism With High Cognitive Abilities

Autism Spectrum Disorder High-Functioning

Autism; Atypical

Autism-Related Speech Delay

Autism Fragile Syndrome X

Treatments

Other: No Intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04100863

PRG-006

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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