A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
Withdrawn before enrolling
Conditions studied: 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
In brief
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.
Key facts
- Study ID
- NCT04100863
- Run by
- ProgenaBiome
- People needed
- 0
- Starts
- 2020-03-02
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2025-06-05
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- ProgenaBiome — Ventura, California, United States
Full record on ClinicalTrials.gov
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