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

ProgenaBiome

Status: Enrolling

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

Treatments: Other: There is no intervention in this study

Study type: Observational

Funder types: Other

Identifiers

NCT04031469

PRG-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: 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

Trial design

1,000 participants in 1 patient group

General Population

Description:

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

Treatment:

Other: There is no intervention in this study