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

P

ProgenaBiome

Status

Withdrawn

Conditions

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

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04211428
PRG-030

Details and patient eligibility

About

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

Full description

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

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Bipolar Disorder
Description:
Patients with bipolar disorder
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Jordan Daniels, MS; Sabine Hazan, MD

Data sourced from clinicaltrials.gov

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