A Non-Interventional Pilot Study to Explore the Role of G... | NCT04100915

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

NCT04100915

Sponsor

ProgenaBiome

Status

Withdrawn

Last Update Posted

Jun 5, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Myalgic Encephalomyelitis
Chronic Fatigue Syndrome

Interventions

No Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company focus shifted

Expanded Access Info

Start Date

Mar 2, 2020Actual

Primary Completion Date

Mar 2030Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Sep 20, 2019

First Submission Date that Met QC Criteria

Sep 20, 2019

First Posted Date

Sep 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)		Patients diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	There is no intervention for this study	Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	1 year

Secondary Outcomes

Measure	Description	Time Frame
Validation of Sequencing Methods	To validate the methods used to sequence samples	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Refusal by patient to sign informed consent form
Treatment with antibiotics within 2 weeks prior to screening
Treatment with probiotics within 6 weeks prior to screening
History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
Postoperative stoma, ostomy, or ileoanal pouch
Participation in any experimental drug protocol within the past 12 weeks
Treatment with total parenteral nutrition
Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Sabine Hazan, MD	ProgenaBiome	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
ProgenaBiome		Ventura	California	93003	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Only aggregated and deidentified data will be shared with other investigators

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015673	Fatigue Syndrome, Chronic

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D004679	Encephalomyelitis
D000090862	Neuroinflammatory Diseases

Browse Leaves

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Browse Branches

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