Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Summary

Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary/supplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children.

The investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided.

The findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and/or supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.

Conditions

• Perinatal Depression
• PerinatalAnxiety

Interventions

DIETARY_SUPPLEMENT

Probiotics

Combination strain of lactobacillus and bifidobacteria

BEHAVIORAL

Prebiotics

Dietary consult with follow-up to ensure target fiber intake is met.

BEHAVIORAL

Diet Quality

one time dietary consult at enrollment to discuss strategies to improve overall diet.

DIETARY_SUPPLEMENT

Fish oil

1500mg EPA +1000mg DHA daily

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Lotte & John Hecht Memorial Foundation

  collaborator OTHER

• The Canadian College of Naturopathic Medicine

  lead OTHER

Principal Investigators

• Neda Ebrahimi, PhD · Canadian College of Naturopathic Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

43 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-15

Primary Completion

2027-12-31

Completion

2028-03-31

Countries

• Canada

Study Locations