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

Sponsor
ProgenaBiome (Other)
Overall Status
Recruiting
CT.gov ID
NCT04100863
Collaborator
(none)
100
1
39
2.6

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.

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
Actual Study Start Date :
Mar 2, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Individuals with Autism

Individuals who have been diagnosed with autism

Other: No Intervention
There is no intervention for this study.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Validation of Sequencing Methods [1 year]

    To validate the methods used to sequence samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Signed informed consent by parent or legally authorized representative

  2. Male or female patients age 6 and older.

  3. Diagnosis of autism per DSM-V criteria (See appendix)

Exclusion Criteria:
  1. Refusal by parent or legally authorized representative to sign informed consent form

  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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
ProgenaBiome
ClinicalTrials.gov Identifier:
NCT04100863
Other Study ID Numbers:
  • PRG-006
First Posted:
Sep 24, 2019
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021