Exploring the link between maternal gut microbiome and perinatal depression and anxiety
Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial
This study is testing if improving gut health with diet and supplements can help pregnant women who have a history of depression and anxiety feel better during and after pregnancy.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | The Canadian College of Naturopathic Medicine Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06074250 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the gut microbiome and perinatal depression and anxiety (PDA) in pregnant women with a history of these conditions. A total of 100 participants will be recruited and randomly assigned to one of four groups receiving dietary and supplemental interventions, including fish oil, probiotics, and prebiotics. Participants will complete six study visits over 9-12 months, during which dietary intake, mental health scores, and stool samples will be collected to assess the feasibility of the intervention. The study aims to optimize gut health as a potential management strategy for PDA.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-43 with a history of depression or anxiety who are currently stable and between 12-35 weeks of gestation.
Not a fit: Patients with a BMI of 30 or higher, major mental health disorders, or severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological approach to managing perinatal depression and anxiety, improving maternal and child health outcomes.
How similar studies have performed: Other studies have shown promising results in using dietary interventions to influence gut microbiome and mental health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Science Center — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Neda Ebrahimi, PhD — Canadian College of Naturopathic Medicine
- Study coordinator: Neda Ebrahimi, PhD
- Email: nebrahimi@ccnm.edu
- Phone: 416-498-1255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.