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

SuspendedN/A

Sponsor: ProgenaBiome

Conditions: Gut Microbiome, Gastrointestinal Microbiome, Autism, Autism Spectrum Disorder, Autism Spectrum Disorder High-Functioning

Interventions: There is no intervention in this study

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 1\. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
* 2\. Male or female patients of any age (interest is given to children to compare with mothers).

Exclusion Criteria:

* 1\. Refusal to sign informed consent form
* 2\. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
* 3\. Postoperative stoma, ostomy, or ileoanal pouch
* 4\. Participation in any experimental drug protocol within the past 12 weeks
* 5\. Treatment with total parenteral nutrition
* 6\. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
* 7\. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Locations (1)

Ventura, California, United States