A Non-Interventional Pilot Study to Explore the Role of G... | NCT04211428

Studies
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder

NCT04211428

Sponsor

ProgenaBiome

Status

Withdrawn

Last Update Posted

Jun 5, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bipolar Disorder
Bipolar I Disorder
Bipolar II Disorder
Bipolar Type I Disorder
Bipolar Disorder Mild
Bipolar Disorder Moderate
Bipolar Disorder Severe

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Withdrawn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 shifted focus

Expanded Access Info

Start Date

Mar 2, 2020Actual

Primary Completion Date

Mar 2030Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Dec 23, 2019

First Submission Date that Met QC Criteria

Dec 23, 2019

First Posted Date

Dec 26, 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.

Detailed Description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to bipolar disorder

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

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
Bipolar Disorder		Patients with bipolar disorder	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	There is no intervention for this study	Bipolar Disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 with bipolar disorder	Three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
Male or female of all ages.
Greater than seven endorsements on the bipolar disorder questionnaire.

Exclusion Criteria:

Refusal to sign informed consent form
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with bipolar disorder

Sampling Method

Non-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

Description

There is no plan to share IPD.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided