ClinicalTrials.gg
WithdrawnNCT04100915Updated Jun 5, 2025

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS

An observational study in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by ProgenaBiome. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by ProgenaBiome · Observational

Why this study was withdrawn
Company focus shifted

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 86 studies in Fatigue Syndrome, Chronic with a site in United States — 21 open to participants now, 24 under way, none of them phase 3. Fatigue Syndrome, Chronic · United States.

Enrollment
25th of 26
0 · median 152
Started
2020
with 4 others
Observational
26 of 86
7 open now
Registered
51st of 86
by date

Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, this one is the 25th largest by enrollment of the 26 observational ones that give a count, is one of 5 that started in 2020, is one of 26 observational ones, and was the 51st registered.

Fatigue Syndrome, Chronic

264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.

Browse Fatigue Syndrome, Chronic studies →

Open to participants now

21 of the 86 studies in Fatigue Syndrome, Chronic with a site in United States are open now. Recruiting first, the newest first:

16 more — sign in →

All 21 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

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 regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

03

Conditions studied

  • Myalgic Encephalomyelitis
  • Chronic Fatigue Syndrome
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

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 by patient
  2. Male or female patients age 18 and older.
  3. Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) based on the proposed diagnostic criteria of the National Academy of Medicine

Exclusion criteria

Exclusion Criteria:

  1. Refusal by patient to sign form
  2. Treatment with antibiotics within 2 weeks prior to screening
  3. Treatment with probiotics within 6 weeks prior to screening
  4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
  5. Postoperative stoma, ostomy, or ileoanal pouch
  6. Participation in any experimental drug protocol within the past 12 weeks
  7. Treatment with total parenteral nutrition
  8. Any evidence of disease that could interfere with the subject's ability to enter the trial
  9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud
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
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

    Patients diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

    Other: No Intervention

Interventions

  • OtherNo Intervention

    There is no intervention for this study

06

What researchers measure

Primary outcomes

  1. Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) 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 correlated to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

    Time frame: 1 year

Secondary outcomes

  1. Validation of Sequencing Methods

    To validate the methods used to sequence samples

    Time frame: 1 year

07

Study locations

1 site
  • ProgenaBiome
    Ventura, California 93003, United States
08

References and documents

Individual participant data

Plan to share: Undecided — Only aggregated and deidentified data will be shared with other investigators

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Mar 2030, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2019
First posted
Sep 24, 2019
StartActual
Mar 2, 2020
Primary completionEst.
Mar 2030
CompletionEst.
Jul 2030
Last update
Jun 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04100915
Lead sponsor
ProgenaBiome
Responsible party
Sponsor
First posted
Sep 24, 2019
Start date
Mar 2, 2020
Primary completion
Mar 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Jun 5, 2025

Study contacts

Sabine Hazan, MD
principal investigator · ProgenaBiome

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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