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Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

RecruitingPhase 2, Phase 3Ages 18 Years - 43 YearsFemaleThe Canadian College of Naturopathic Medicine
NCT06074250 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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
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What it tests

  • Fish oil
  • Probiotics
  • Prebiotics
  • Diet Quality
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Where

1 site
Sunnybrook Health Science Center
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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