A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
Study Details
Study Description
Brief Summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Individuals with Autism Individuals who have been diagnosed with autism |
Other: No Intervention
There is no intervention for this study.
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Outcome Measures
Primary Outcome Measures
- Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing [1 year]
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
Secondary Outcome Measures
- Validation of Sequencing Methods [1 year]
To validate the methods used to sequence samples
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent by parent or legally authorized representative
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Male or female patients age 6 and older.
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Diagnosis of autism per DSM-V criteria (See appendix)
Exclusion Criteria:
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Refusal by parent or legally authorized representative to sign informed consent form
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Treatment with antibiotics within 2 weeks prior to screening
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Treatment with probiotics within 6 weeks prior to screening
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History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
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Postoperative stoma, ostomy, or ileoanal pouch
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Participation in any experimental drug protocol within the past 12 weeks
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Treatment with total parenteral nutrition
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Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | ProgenaBiome | Ventura | California | United States | 93003 |
Sponsors and Collaborators
- ProgenaBiome
Investigators
- Principal Investigator: Sabine Hazan, MD, ProgenaBiome
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRG-006