Participate in Primary Research

Targeting Maternal Gut Microbiome to Improve Mental Health Outcomes - A Pilot Feasibility Trial

Perinatal depression and anxiety (PDA) can occur often in new and expectant mothers. Those with a history of mood and anxiety disorders are at the greatest risk of experiencing PDA during future pregnancies. There is some uncertainty about what safe effective pharmaceutical options exist, which has led to a greater need to explore non-pharmaceutical options for PDA. Changes in the make-up of gut microbiome has been associated with various concerns during pregnancy and these changes are thought to be at least partially at play. While the relation between PDA and the microbiome has not been explored, evidence suggests that nutritional interventions, with fiber, fish oils, and probiotics, may play a favorable role in neuropsychiatric outcomes during and after pregnancy. The primary objective of the present study is to assess the feasibility and acceptability of a combination of non-pharmacological interventions in currently stable and pregnant women with a history of anxiety and/or depression.

Participant responsibilities:

Starting in their 2nd trimester, people taking part in the study will participate in six (6) study visits; two (2) before delivery and four (4) spaced out every 4-12 weeks after delivery spaced out over 1 year. They may be given recommendations on how to improve their food choices, an omega-3 fatty acid product, probiotics, or some combination of the above. If someone wants to take part in this study, but not take any of the above, they can still participate. At each study visit, there will be questionnaires to help understand whether any changes in health occur during the study and a kit for at-home stool collection. Most study visits take place virtually, although some can be done in-person. You must be a current patient of Sunnybrook Hospital’s Clinics (e.g. DAN Women and Babies) to participate in the study.

Eligibility requirements:

  • A person aged 18-43 years old
  • At 12-35 weeks of gestation at time of enrolment
  • Stable both financially and in their personal relationship
  • In a married or common-law relationship
  • Clinical diagnosis of lifetime depression/anxiety or PDA, but stable at the time of recruitment
  • Additional criteria will be reviewed in a screening phone call

Location of study:

Sunnybrook Health Sciences Centre (2075 Bayview Ave, Toronto, Ontario)

Duration:

The study will last up to 12 months (3-6 months before delivery and 9 months after delivery)

Compensation:

Participants will receive a $20 gift card for completion of each study visit. Participants will also receive any of the study products that they have been assigned to.

Contact:

Please contact gutbugs@ccnm.edu if interested or want to know more.

Link:

We wish to acknowledge the support and involvement of the following organizations in this study:
Lotte and John Hecht Foundation
Genestra
Sunnybrook

Status:
Recruiting