RecruitingPhase 2Phase 3NCT06074250

Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

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


Sponsor

The Canadian College of Naturopathic Medicine

Enrollment

100 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 43 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring the connection between depression or anxiety during pregnancy (called perinatal depression and anxiety) and the gut microbiome — the community of bacteria living in your digestive system. Researchers want to understand how gut health may relate to mental health in pregnant women. **You may be eligible if...** - You are a woman between 18 and 43 years old - You are between 12 and 35 weeks pregnant - You have been diagnosed with depression or anxiety at some point in your life, or currently during pregnancy, but are currently doing well - You do not smoke, drink alcohol, or use recreational drugs - You are financially stable - You speak English **You may NOT be eligible if...** - Your BMI is 30 or above - You have a low income that makes participation difficult - You currently smoke, drink, or use recreational drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTFish oil

1500mg EPA +1000mg DHA daily

DIETARY_SUPPLEMENTProbiotics

Combination strain of lactobacillus and bifidobacteria

BEHAVIORALPrebiotics

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

BEHAVIORALDiet Quality

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


Locations(1)

Sunnybrook Health Science Center

Toronto, Ontario, Canada

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NCT06074250


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