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

Withdrawn before enrolling

Conditions studied: Depression, Clinical Depression, Depression, Anxiety, Depression, Postpartum, Depression, Endogenous, Depression in Remission, Depression Chronic, Depression Moderate, Depression Severe

In brief

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

Key facts

Study ID

NCT04211467

Run by

ProgenaBiome

People needed

0

Starts

2020-03-02

Expected to finish

2030-07-01

Last updated by the study team

2025-06-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
• Diagnosis of depression based on DSM-V criteria

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

Where it is running

• ProgenaBiome — Ventura, California, United States

Full record on ClinicalTrials.gov

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