ClinicalTrials.gg
SuspendedNCT04031469Updated Sep 21, 2026

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

An observational study in Gut Microbiome, Gastrointestinal Microbiome and Autism, sponsored by ProgenaBiome. Suspended at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by ProgenaBiome · Observational

Why this study was suspended
Administrative
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,000
Ages
12 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • 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

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
03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 101 across 189 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

ProgenaBiome is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults and minors of any age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Signed , 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

Exclusion Criteria:

  • 1. Refusal to sign 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • General Population

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

    Other: There is no intervention in this study

Interventions

  • OtherThere is no intervention in this study

    There is no intervention in this study

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: One year

Secondary outcomes

  1. Validation of Sequencing Methods

    To validate the methods used to sequence samples

    Time frame: One year

07

Study locations

1 site
  • Sabine Hazan
    Ventura, California 93003, United States
08

References and documents

Publications

  • 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. PubMed 35483736 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04031469
Lead sponsor
ProgenaBiome
Responsible party
Sponsor
First posted
Jul 24, 2019
Start date
Jul 11, 2019
Primary completion
Jul 10, 2030 (estimated)
Completion
Dec 10, 2030 (estimated)
Last update
Sep 21, 2026

Study contacts

Sabine Hazan, MD
study director · ProgenaBiome

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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