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

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

Why the study stopped: Administrative

Suspended

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Key information

Conditions

Gut Microbiome Acne Acne Vulgaris Acneiform Eruptions Adenoma Alzheimer Dementia Alzheimer Dementia (AD) Alzheimer Disease Alzheimer Disease (AD) Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS) Anxiety Anxiety Disorder Generalized Anxiety Disorders Arthritis Arthritis, Rheumatoid Autism Autism Spectrum Disorder Autism Spectrum Disorder High-Functioning Autistic Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Bacterial Infections Bacterial Infections and Mycoses Basal Ganglia Diseases Behavior Behavioral Symptoms Bipolar Bipolar 1 Disorder Bipolar Disorder Bipolar Disorder (BD) Bipolar Disorder I and II Bipolar and Related Disorders Borrelia Infections Brain Diseases Cancer Celiac Celiac Disease Celiac Sprue Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Child Development Disorders, Pervasive Cholesterol Cholesterol Level, High Chronic Disease Chronic Fatigue Syndrome (CFS) Chronic Urinary Tract Infection Colitis Colitis, Ulcerative Colon Cancer Colonic Diseases Colonic Diseases, Functional Colonic Neoplasms Colorectal Neoplasms Compulsive Personality Disorder Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Constipation Constipation Chronic Idiopathic Crohn Crohn Colitis Crohn Disease Crohn Disease (CD) Crohn Disease Colon Crystal Arthropathies Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Depression Disorder Depression in Adults Depressive Disorder Depressive Disorder, Major Dermatitis Diabetes Diabetes (DM) Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Disease Attributes Dyslipidemias Eczema Eczema Atopic Dermatitis Encephalomyelitis Endocrine System Diseases Epidermolysis Bullosa Epidermolysis Bullosa (EB) Fatigue Syndrome, Chronic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Microbiome Gastrointestinal Neoplasms Generalized Anxiety Disorder Genetic Diseases, Inborn Glucose Metabolism Disorders Gout Gram-Negative Bacterial Infections Headache Disorders Headache Disorders, Primary Hypercholesterolemia Hyperlipidemias IBS (Irritable Bowel Syndrome) IBS - Irritable Bowel Syndrome Immune System Diseases Infections Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Irritable Bowel Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Joint Diseases Lipid Metabolism Disorders Lupus Lupus Erythematosus Lyme Arthritis Lyme Borreliosis, Nervous System Lyme Disease Lyme Disease, Chronic Lyme Neuroborreliosis ME/CFS Major Depressive Disorder (MDD) Malabsorption Syndromes Mental Disorders Mesothelioma Mesothelioma Malignant Metabolic Diseases Metabolism, Inborn Errors Migraine Migraine Disorder Migraine Disorders Mood Disorders Motor Neuron Disease Movement Disorders Multiple Sclerosis Multiple Sclerosis (MS) - Relapsing-remitting Multiple Sclerosis (MS) Primary Progressive Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Muscular Diseases Musculoskeletal Diseases Myalgic Encephalomyelitis Myalgic Encephalomyelitis (ME) Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Myasthaenia Gravis Myasthenia Gravis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Nervous System Diseases Nervous System Neoplasms Neurocognitive Disorders Neurodegenerative Diseases Neurodevelopmental Disorders Neuroinflammatory Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Nutritional and Metabolic Diseases Obsessive - Compulsive Disorder Obsessive Compulsive Disorder (OCD) Obsessive Compulsive Disorder OCD Obsessive-Compulsive Disorder PARKINSON DISEASE (Disorder) Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Parkinson Disease Parkinson Disease (PD) Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Personality Disorders Post-Infectious Disorders Post-Lyme Disease Syndrome Proteostasis Deficiencies Psoriasis Psoriasis Annularis Psoriasis Chronic Purine-Pyrimidine Metabolism, Inborn Errors Rectal Diseases Rheumatic Diseases Rheumatoid Arthritis (RA) Rheumatoid Arthritis - Rheumatism Sebaceous Gland Diseases Signs and Symptoms Signs and Symptoms, Digestive Skin Abnormalities Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Spinal Cord Diseases Spirochaetales Infections Synucleinopathies TDP-43 Proteinopathies Tauopathies Tick-Borne Diseases Ulcerative Colitis (Disorder) Ulcerative Colitis (UC) Ulcerative Colitis Acute Ulcerative Colitis Chronic Vector Borne Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sabine Hazan

Ventura, California, 93003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There is no intervention in this study

Other

There is no intervention in this study

Primary outcomes

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Time frame: 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

Time frame: One year

To validate the methods used to sequence samples

Sponsors and collaborators

Lead sponsor

ProgenaBiome

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2030
Study completion: 2030
First posted: Jul 24, 2019
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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