A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
Reason given: Company focus shifted
Key facts
- Where
- Ventura, United StatesSee the site
Where in United States
- ProgenaBiomeVentura, United StatesNo longer taking part
Trial details
- Who runs it
- ProgenaBiome
- Trial code
- NCT04100863
- Record updated
- 5 June 2025
- Original description
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.Read full original descriptionShow less
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.
Inclusion: 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: Treatment with antibiotics within 2 weeks prior to screening; Treatment with probiotics within 6 weeks prior to screening; Participation in any experimental drug protocol within the past 12 weeks; Treatment with total parenteral nutrition; History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy; Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial; Refusal by parent or legally authorized representative to sign informed consent form; Postoperative stoma, ostomy, or ileoanal pouch; 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.