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

NCT ID: NCT04031469

Last Updated: 2025-07-31

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-11

Study Completion Date

2030-12-10

Brief Summary

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

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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General Population

The general population will have their microbiome sequenced from stool samples provided.

There is no intervention in this study

Intervention Type OTHER

There is no intervention in this study

Interventions

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There is no intervention in this study

There is no intervention in this study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Hazan, MD

Role: STUDY_DIRECTOR

ProgenaBiome

Locations

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Sabine Hazan

Ventura, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35483736 (View on PubMed)

Other Identifiers

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PRG-002

Identifier Type: -

Identifier Source: org_study_id

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