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Search / Trial NCT06074250

Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Launched by THE CANADIAN COLLEGE OF NATUROPATHIC MEDICINE · Oct 6, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Gut Microbiome Gut Brain Axis Diet Omega 3 Fatty Acids Probiotics Fish Oil Mental Health Disorders Perinatal Depression And Anxiety

ClinConnect Summary

This clinical trial is studying how diet and supplements might help improve the gut health of pregnant women and reduce the risk of perinatal depression and anxiety (PDA). PDA is a serious condition that can affect mothers' mental health and their children's long-term development. The researchers believe that by changing the foods these women eat and introducing supplements like probiotics and fish oil, they can positively influence their gut microbiome, which could help improve mood and reduce anxiety during pregnancy.

Women aged 18 to 43 who are between 12 to 35 weeks pregnant and have a history of depression or anxiety may be eligible to participate. If you join the study, you will be randomly assigned to one of four groups: one focusing on diet changes, one taking probiotics, one taking fish oil, or a control group with no intervention. You'll meet with the study team every three months and complete some questionnaires about your mood and diet, along with providing a stool sample to help researchers understand changes in your gut health. This study is important as it lays the groundwork for larger trials that could lead to better support for mothers experiencing mental health challenges during and after pregnancy.

Gender

FEMALE

Eligibility criteria

  • 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

About The Canadian College Of Naturopathic Medicine

The Canadian College of Naturopathic Medicine (CCNM) is a leading institution dedicated to advancing the field of naturopathic medicine through education, research, and clinical practice. As a prominent clinical trial sponsor, CCNM focuses on the rigorous investigation of naturopathic therapies and their efficacy in promoting health and wellness. By fostering a collaborative environment, CCNM engages with healthcare professionals, researchers, and the community to support innovative clinical research initiatives and contribute to the evidence base of complementary and alternative medicine. Through its commitment to high ethical standards and scientific integrity, CCNM aims to enhance the understanding and application of naturopathic care within the broader healthcare landscape.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Neda Ebrahimi, PhD

Principal Investigator

Canadian College of Naturopathic Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported