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

NCT04031469 — Suspended, 1000 participants, ProgenaBiome

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Registry	NCT04031469
Status	Suspended - Administrative
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	ProgenaBiome (Other)
Conditions	Gut Microbiome, Gastrointestinal Microbiome, Autism, Autism Spectrum Disorder, Autism Spectrum Disorder High-Functioning, Alzheimer Disease, Alzheimer Dementia (AD), Alzheimer Dementia, Alzheimer Disease (AD), Crohn, Crohn Colitis, Crohn Disease (CD), Crohn Disease Colon, Myalgic Encephalomyelitis, ME/CFS, Myalgic Encephalomyelitis (ME), Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Psoriasis, Psoriasis Annularis, Psoriasis Chronic, Chronic Urinary Tract Infection, Ulcerative Colitis (Disorder), Ulcerative Colitis (UC), Ulcerative Colitis Acute, Ulcerative Colitis Chronic, Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive, Constipation Chronic Idiopathic, Constipation, Celiac, Celiac Disease, Celiac Sprue, Lyme Arthritis, Lyme Borreliosis, Nervous System, Lyme Disease, Chronic, Cholesterol, Cholesterol Level, High, Cancer, Colon Cancer, Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis, Rheumatoid Arthritis (RA), Rheumatoid Arthritis - Rheumatism, Chronic Fatigue Syndrome (CFS), PARKINSON DISEASE (Disorder), Parkinson Disease, Parkinson Disease (PD), Depression, Major Depressive Disorder (MDD), Depression Disorder, Depression in Adults, Anxiety, Anxiety Disorder Generalized, Obsessive Compulsive Disorder (OCD), Obsessive Compulsive Disorder OCD, Obsessive - Compulsive Disorder, Bipolar, Bipolar 1 Disorder, Bipolar Disorder (BD), Bipolar Disorder I and II, Bipolar and Related Disorders, Migraine, Migraine Disorder, Diabetes (DM), Diabetes, Lupus, Lupus Erythematosus, Epidermolysis Bullosa (EB), Mesothelioma, Mesothelioma Malignant, IBS (Irritable Bowel Syndrome), Irritable Bowel, IBS - Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS), Eczema, Eczema Atopic Dermatitis, Acne, Myasthaenia Gravis, Gout
Interventions	There is no intervention in this study (Other)
Dates	start 2019-07-11, primary completion 2030-07-10 (estimated), completion 2030-12-10 (estimated), first posted 2019-07-24, last updated 2026-09-21
Locations	1 site in United States

-Summary

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

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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.

+Arms and interventions

Arm	Type	Interventions	Description
General Population		Other: There is no intervention in this study	The general population will have their microbiome sequenced from stool samples provided.

There is no intervention in this study (Other): There is no intervention in this study

+Outcome measures

Primary outcomes

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [One 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 gastrointestinal disease types.

Secondary outcomes

Validation of Sequencing Methods [One year]: To validate the methods used to sequence samples

+Eligibility

Sex: All, ages: 12 Years to any, accepts healthy volunteers

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)

Facility	City	Country	Status
Sabine Hazan	Ventura, California	United States

+Publications

Results publication: Hazan S, Stollman N, Bozkurt HS, Dave S, Papoutsis AJ, Daniels J, Barrows BD, Quigley EM, Borody TJ. Lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity. BMJ Open Gastroenterol. 2022 Apr;9(1):e000871. doi: 10.1136/bmjgast-2022-000871. PMID 35483736

+Investigators

Sabine Hazan, MD, Study director, ProgenaBiome