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

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04031469
Enrollment
1000
Registered
2019-07-24
Start date
2019-07-11
Completion date
2030-12-10
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne, Alzheimer Dementia, Alzheimer Dementia (AD), Alzheimer Disease, Alzheimer Disease (AD), Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis (ALS), Anxiety, Anxiety Disorder Generalized, Autism, Autism Spectrum Disorder, Autism Spectrum Disorder High-Functioning, Bipolar, Bipolar 1 Disorder, Bipolar and Related Disorders, Bipolar Disorder (BD), Bipolar Disorder I and II, Cancer, Celiac, Celiac Disease, Celiac Sprue, Cholesterol, Cholesterol Level, High, Chronic Fatigue Syndrome (CFS), Chronic Urinary Tract Infection, Colon Cancer, Constipation, Constipation Chronic Idiopathic, Crohn, Crohn Colitis, Crohn Disease (CD), Crohn Disease Colon, Depression, Depression Disorder, Depression in Adults, Diabetes, Diabetes (DM), Eczema, Eczema Atopic Dermatitis, Epidermolysis Bullosa (EB), Gastrointestinal Microbiome, Gout, Gut Microbiome, IBS - Irritable Bowel Syndrome, IBS (Irritable Bowel Syndrome), Irritable Bowel, Irritable Bowel Syndrome (IBS), Lupus, Lupus Erythematosus, Lyme Arthritis, Lyme Borreliosis, Nervous System, Lyme Disease, Chronic, Major Depressive Disorder (MDD), ME/CFS, Mesothelioma, Mesothelioma Malignant, Migraine, Migraine Disorder, Multiple Sclerosis, Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) - Relapsing-remitting, Myalgic Encephalomyelitis, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Myalgic Encephalomyelitis (ME), Myasthaenia Gravis, Obsessive - Compulsive Disorder, Obsessive Compulsive Disorder OCD, Obsessive Compulsive Disorder (OCD), Parkinson Disease, PARKINSON DISEASE (Disorder), Parkinson Disease (PD), Psoriasis, Psoriasis Annularis, Psoriasis Chronic, Rheumatoid Arthritis (RA), Rheumatoid Arthritis - Rheumatism, Ulcerative Colitis Acute, Ulcerative Colitis Chronic, Ulcerative Colitis (Disorder), Ulcerative Colitis (UC)

Keywords

Microbiome, autism, ASD, Myalgic encephalomyelitis, ME/CFS, Psoriasis, Chronic UTI, Chronic Urinary Tract Infection, Ulcerative Colitis, UC, Multiple Sclerosis, MS, Chronic Constipation, Constipation, Celiac disease, Celic Sprue, Lyme disease, Elevated Cholesterol, Colorectal Cancer, Cancer, Amyotrophic Lateral Sclerosis, ALS, Rheumatoid Arthritis, RA, Chronic Fatigue, Alzheimer disease, Chrohns colitis, Crohn, Alzheimer, Parkinson, depression, major depressive disorder, OCD, Obsessive-Compulsive disorder, Biopolar, Bipolar disorder, Migraine, Migraine headache, Diabetes, DM, Diabetes DM, Lupus, Lupus eruthematosus, Epidermolysis Bullosa, Mesothelioma, IBS, Irritable Bowel Syndrome, Eczema, Acne, Myasthenia Gravis, Gout

Brief summary

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

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.

Interventions

There is no intervention in this study

Sponsors

ProgenaBiome
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome SequencingOne yearRelative 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

MeasureTime frameDescription
Validation of Sequencing MethodsOne yearTo validate the methods used to sequence samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026