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WithdrawnNo phase

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

Key facts

Who runs it
ProgenaBiome
Where
Ventura, United StatesSee the site
Trial code
Status
Withdrawn
Started
2 Mar 2020
Expected to end
Jul 2030
Type of study
Observational
Record updated
5 June 2025
Why it stopped
Company shifted focus

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

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

Who cannot take part

  • Participation in any experimental drug protocol within the past 12 weeks
  • Treatment with total parenteral nutrition
  • History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy
  • Refusal to sign informed consent form
  • Postoperative stoma, ostomy, or ileoanal pouch

Where in United States

  • ProgenaBiomeVentura, United States

About the trial

What the trial wants to find out

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

The group in the trial

  • Depression

    Patients who have been diagnosed with depression

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
5 June 2025
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Depression (NCT04211467) – Frontlight Research