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

• Sponsor: ProgenaBiome (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04211428
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder; Bipolar Type I Disorder; Bipolar Disorder Mild; Bipolar Disorder Moderate; Bipolar Disorder Severe	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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder
• Actual Study Start Date: Mar 2, 2020
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [Three years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

1. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent

1. Male or female of all ages.

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProgenaBiome	Ventura	California	United States	93003

Sponsors and Collaborators

• ProgenaBiome

Investigators

• Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProgenaBiome
• ClinicalTrials.gov Identifier: NCT04211428
• Other Study ID Numbers: PRG-030
• First Posted: Dec 26, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Disease; Bipolar Disorder

Study Results

No Results Posted as of Sep 5, 2021