Exploring the link between maternal gut microbiome and perinatal depression and anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between the gut microbiome and perinatal depression and anxiety (PDA) in pregnant women with a history of these conditions. A total of 100 participants will be recruited and randomly assigned to one of four groups receiving dietary and supplemental interventions, including fish oil, probiotics, and prebiotics. Participants will complete six study visits over 9-12 months, during which dietary intake, mental health scores, and stool samples will be collected to assess the feasibility of the intervention. The study aims to optimize gut health as a potential management strategy for PDA.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Women 18-43 years old
* 12-35 weeks of gestation
* Non-smoker/alcohol/recreational drug user
* Financially stable
* Clinical diagnosis of lifetime depression/anxiety or PDA but currently well
* English speaking

Exclusion Criteria:

* Body Mass Index (BMI)≥30
* Low income (unable to afford basic daily needs (i.e., shelter, food, etc.)
* Diagnosis with other major mental health disorders (Bipolar, Psychosis, Addiction, Schizophrenia);
* Diagnosis with other severe medical conditions (i.e. epilepsy, neurological disorders, etc.)
* Allergies to fish oils/ingredients in supplements
* Conditions that require repeated/chronic antibiotic usage
* Having a child with significant mental/physical disability
* Single mothers without any kind of family support,
* Cigarette, alcohol and recreational drug users
* Women unwilling to switch to study product(s)
* Multiparous women with young children (i.e. one or more children less than 4 years of age at the time of delivery)
* Non-English Readers/Speakers

Where it's running

• Sunnybrook Health Science Center
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Neda Ebrahimi, PhD — Canadian College of Naturopathic Medicine
• Study coordinator: Neda Ebrahimi, PhD
• Email: nebrahimi@ccnm.edu
• Phone: 416-498-1255

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.