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

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

Study Overview

• Status: Withdrawn
• Conditions: Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder; Bipolar Type I Disorder; Bipolar Disorder Mild; Bipolar Disorder Moderate; Bipolar Disorder Severe
• Intervention / Treatment: Other: No intervention

Detailed Description

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

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • ProgenaBiome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with bipolar disorder

Description

Inclusion Criteria:

1. 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

2. Male or female of all ages.
3. Greater than seven endorsements on the bipolar disorder questionnaire.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bipolar Disorder; Patients with bipolar disorder	Other: No intervention; There is no intervention for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ProgenaBiome
• Investigators: Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder
• Other Study ID Numbers: PRG-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No