A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
NCT ID: NCT04100863
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-03-02
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Individuals with Autism
Individuals who have been diagnosed with autism
No Intervention
There is no intervention for this study.
Interventions
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No Intervention
There is no intervention for this study.
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients age 6 and older.
3. Diagnosis of autism per DSM-V criteria (See appendix)
Exclusion Criteria
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. 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
6 Years
ALL
No
Sponsors
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ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: PRINCIPAL_INVESTIGATOR
ProgenaBiome
Locations
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ProgenaBiome
Ventura, California, United States
Countries
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Other Identifiers
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PRG-006
Identifier Type: -
Identifier Source: org_study_id
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