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Trial record 2 of 3 for:    progenabiome | autism

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

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ClinicalTrials.gov Identifier: NCT04100863
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Tracking Information
First Submitted Date September 20, 2019
First Posted Date September 24, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date March 2, 2020
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2019)
Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 20, 2019)
Validation of Sequencing Methods [ Time Frame: 1 year ]
To validate the methods used to sequence samples
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
Official Title A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
Stool samples
Sampling Method Probability Sample
Study Population Individuals ages 6 and older who have been diagnosed with Autism
Condition
  • Autism
  • Autism Spectrum Disorder
  • Autistic Disorder
  • Autism, Akinetic
  • Autism; Atypical
  • Autism; Psychopathy
  • Autism Fragile Syndrome X
  • Autism With High Cognitive Abilities
  • Autism-Related Speech Delay
  • Autism, Susceptibility to, 6
  • Autism Spectrum Disorder High-Functioning
  • Autistic Thinking
  • Autism, Susceptibility to, X-Linked 6
  • Autistic Behavior
Intervention Other: No Intervention
There is no intervention for this study.
Study Groups/Cohorts Individuals with Autism
Individuals who have been diagnosed with autism
Intervention: Other: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 20, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04100863
Other Study ID Numbers ProgenaBiome-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Only aggregated and deidentified data will be shared with other researchers.
Responsible Party ProgenaBiome
Study Sponsor ProgenaBiome
Collaborators Not Provided
Investigators
Principal Investigator: Sabine Hazan, MD ProgenaBiome
PRS Account ProgenaBiome
Verification Date April 2021