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Gut bacteria may hold clues to dozens of diseases

NCT ID NCT04031469

NEW Knowledge-focused Sponsor: ProgenaBiome Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are sequencing the gut microbiomes of people with a wide range of conditions, from autism and Alzheimer's to Crohn's disease and multiple sclerosis, to see whether bacterial patterns differ by disease. The study also enrolls healthy participants for comparison. By matching microbiome data with patient medical records, the team aims to find links between specific gut bacteria and specific diseases. This is an observational study, so participants receive no treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers find distinct bacterial patterns linked to specific diseases, that could guide future tests or treatments that target the gut microbiome.
What could go wrong
This study only looks for correlations, so it cannot prove that gut bacteria cause any disease. The findings may be too broad or inconsistent to lead to a usable treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults and minors of any age

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris Alzheimer disease amyotrophic lateral sclerosis anxiety anxiety disorder atopic eczema autism autism spectrum disorder Bipolar and Related Disorders bipolar disorder bipolar I disorder cancer celiac disease chronic progressive multiple sclerosis colon carcinoma colonic neoplasm colorectal neoplasm constipation disorder Crohn disease Crohn's colitis Depression depressive disorder diabetes mellitus Eczema epidermolysis bullosa generalized anxiety disorder gout Hypercholesterolemia irritable bowel syndrome lupus erythematosus Lyme disease Lyme Neuroborreliosis major depressive disorder malignant mesothelioma mesothelioma migraine disorder multiple sclerosis myalgic encephalomeyelitis/chronic fatigue syndrome myasthenia gravis neoplasm obsessive-compulsive disorder obsessive-compulsive personality disorder Parkinson disease Post-Lyme Disease Syndrome primary progressive multiple sclerosis psoriasis relapsing-remitting multiple sclerosis rheumatoid arthritis ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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 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) - relapsing-remitting Multiple sclerosis (MS) primary progressive Myalgic encephalomyelitis Myalgic encephalomyelitis (ME) Myalgic encephalomyelitis/chronic fatigue syndrome Myasthaenia gravis Obsessive - compulsive disorder 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 (disorder) Ulcerative colitis (UC) Ulcerative colitis acute Ulcerative colitis chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sabine Hazan

    Ventura, California, 93003, United States

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