- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04211428
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder
September 2, 2021 updated by: ProgenaBiome
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Ventura, California, United States, 93003
- Recruiting
- ProgenaBiome
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with bipolar disorder
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bipolar Disorder
Patients with bipolar disorder
|
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
Time Frame: 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
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2020
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
July 1, 2023
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 (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bipolar Disorder
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Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
-
University of PittsburghNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOSUnited States
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
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Medical University of South CarolinaMilken InstituteCompletedBipolar Disorder | Bipolar I Disorder | Bipolar II DisorderUnited States
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Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
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University Hospital, Strasbourg, FranceUnknownBipolar Disorder I | Bipolar Disorder II | Rapid Cycling Bipolar Disorder(DSM-IV-TR)France
-
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-
Universiteit AntwerpenUniversitair Ziekenhuis BrusselUnknownDepression | Mood Disorders | Bipolar Disorder | Bipolar Depression | Mental Disorder | Bipolar I Disorder | Bipolar II DisorderBelgium
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