Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Phase 2

Recruiting

• Conditions: Perinatal Depression; PerinatalAnxiety

• Registration Number: NCT06074250
• Lead Sponsor: The Canadian College of Naturopathic Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria<br><br> - Women 18-43 years old<br><br> - 12-35 weeks of gestation<br><br> - Non-smoker/alcohol/recreational drug user<br><br> - Financially stable<br><br> - Clinical diagnosis of lifetime depression/anxiety or PDA but currently well<br><br> - English speaking<br><br>Exclusion Criteria:<br><br> - Body Mass Index (BMI)=30<br><br> - Low income (unable to afford basic daily needs (i.e., shelter, food, etc.)<br><br> - Diagnosis with other major mental health disorders (Bipolar, Psychosis, Addiction,<br> Schizophrenia);<br><br> - Diagnosis with other severe medical conditions (i.e. epilepsy, neurological<br> disorders, etc.)<br><br> - Allergies to fish oils/ingredients in supplements<br><br> - Conditions that require repeated/chronic antibiotic usage<br><br> - Having a child with significant mental/physical disability<br><br> - Single mothers without any kind of family support,<br><br> - Cigarette, alcohol and recreational drug users<br><br> - Women unwilling to switch to study product(s)<br><br> - Multiparous women with young children (i.e. one or more children less than 4 years<br> of age at the time of delivery)<br><br> - Non-English Readers/Speakers

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of participant recruitment;Adherence to Supplement Intake (estimated using unused portion of supplements);Adherence to Supplement Intake (Number of missed doses/week);Adherence to Dietary Protocol (Using food frequency questionnaire);Completion of Study visits(Number of studies with completed tasks)

Secondary Outcome Measures

Name	Time	Method
Study Obstacles (descriptive measures outlining obstacles)