WithdrawnNot Applicable

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

Stopped: Company shifted focus

United States0Started 2020-03-02

Plain-language summary

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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Timeframe: Three years

Trial details

NCT IDNCT04211467

SponsorProgenaBiome

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-03

View on ClinicalTrials.gov More Depression trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

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