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

NCT04211428 | Withdrawn DMC

• 1 other identifier: PRG-030
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bipolar Disorder

Patients with bipolar disorder

Other: No intervention

Interventions

No intervention OTHER

There is no intervention for this study

Bipolar Disorder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with bipolar disorder

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)