Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 43Years
FEMALE
NCT06074250

Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Led by The Canadian College of Naturopathic Medicine · Updated on 2024-08-27

100

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

Sponsors

T

The Canadian College of Naturopathic Medicine

Lead Sponsor

S

Sunnybrook Health Sciences Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Who Can Participate

Age: 18Years - 43Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 18-43 years old
  • Between 12 and 35 weeks of pregnancy
  • Non-smoker, no alcohol or recreational drug use
  • Financially stable
  • Clinical diagnosis of lifetime depression, anxiety, or perinatal depression/anxiety but currently well
  • English speaking
Not Eligible

You will not qualify if you...

  • Body Mass Index (BMI) of 30 or higher
  • Low income unable to afford basic daily needs (shelter, food, etc.)
  • Diagnosed with major mental health disorders such as bipolar disorder, psychosis, addiction, or schizophrenia
  • Diagnosed with severe medical conditions like epilepsy or neurological disorders
  • Allergic to fish oils or ingredients in supplements
  • Conditions requiring repeated or chronic antibiotic use
  • Having a child with significant mental or physical disability
  • Single mother without family support
  • Current cigarette, alcohol, or recreational drug use
  • Unwillingness to switch to study products
  • Having one or more children under 4 years old at delivery
  • Non-English readers or speakers

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Science Center

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

N

Neda Ebrahimi, PhD

CONTACT

S

Sophie Grigoriadis, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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