Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Phase 2

Recruiting

• Conditions: PerinatalAnxiety; Perinatal Depression
• Interventions: Dietary Supplement: Fish oil; Behavioral: Diet Quality; Dietary Supplement: Probiotics; Behavioral: Prebiotics

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

Brief 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.

Detailed Description

Pregnant women with a history of anxiety and/or depression \& currently stable, will be recruited and randomized or assigned to one of four study groups. A total of 100 will be recruited and required to complete six study visits, one every 3 months. At each visit, data on dietary intake, mental health scores, and stool samples will be collected using appropriate tools. All visits will be completed virtually, unless participants need in-person follow-ups.

The final visit is expected to occur between 9-12 months after delivery. The primary outcome for this study is feasibility, measured by: recruiting the targeted number of participant within the anticipated timeframe, and completion of at least 4 of the 6 visits by each participant.

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Status Verified: 2024-08
• Study Start: 2024-08-15
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-27
• Primary Completion: 2027-12
• Study Completion: 2028-03

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gutboost	Fish oil	Women in this arm will receive a daily probiotic and fish oil supplement from the time of enrollment till 1 year postpartum.
Gutnone	Diet Quality	Women in this arm will only be receiving standard care by their obstetrician, and a one time, 30 minutes consult on how to improve baseline diet quality to meet pregnancy needs will be provided by a dietician at the time of enrollment.
Gutopia	Prebiotics	Women in this arm will receive dietary modification, fish oil and probiotics from the time of enrollment till completion of last study visit (12 months postpartum). The dietary modification will be conducted by a dietician that will provide feedback on the participants diet at enrollment, ways to improve diet quality to meet pregnancy needs, and increase prebiotic foods. Weekly follow-ups will be conducted by the research team to ensure dietary target is met and to help address challenges in doing so. The initial dietary consult will be 30-45 minutes long with 10-15 minute for each subsequent follow-up.
Gutopia	Fish oil	Women in this arm will receive dietary modification, fish oil and probiotics from the time of enrollment till completion of last study visit (12 months postpartum). The dietary modification will be conducted by a dietician that will provide feedback on the participants diet at enrollment, ways to improve diet quality to meet pregnancy needs, and increase prebiotic foods. Weekly follow-ups will be conducted by the research team to ensure dietary target is met and to help address challenges in doing so. The initial dietary consult will be 30-45 minutes long with 10-15 minute for each subsequent follow-up.
Gutopia	Probiotics	Women in this arm will receive dietary modification, fish oil and probiotics from the time of enrollment till completion of last study visit (12 months postpartum). The dietary modification will be conducted by a dietician that will provide feedback on the participants diet at enrollment, ways to improve diet quality to meet pregnancy needs, and increase prebiotic foods. Weekly follow-ups will be conducted by the research team to ensure dietary target is met and to help address challenges in doing so. The initial dietary consult will be 30-45 minutes long with 10-15 minute for each subsequent follow-up.
Gutless	Fish oil	Women in this arm will receive fish oil and placebo probiotic from the time enrollment till 1 year postpartum .
Gutboost	Probiotics	Women in this arm will receive a daily probiotic and fish oil supplement from the time of enrollment till 1 year postpartum.

Primary Outcome Measures

Name	Time	Method
Feasibility of participant recruitment	20 months	Time taken to recruit 100 participants in total and successfully randomize/assign 25 participants per study arm.
Adherence to Dietary Protocol (Using food frequency questionnaire)	2 years	Adherence to the dietary protocol in Group A, will be measured at each study visit and in between study visits to ensure the dietary target is met (i.e. the number of daily servings of specific foods are consumed), and to address and document challenges in reaching the targets.
Completion of Study visits(Number of studies with completed tasks)	2 years	At each visit participants are expected to provide (1)dietary intake using myfitnesspal, (2) Mental health Scores using Edinburgh Postnatal Depression Scale (EPDS) and General Anxiety Disorder-7 (GAD-7) scales, (3) one stool sample, and 4)provide update on lifestyle and health status. A study visit will be marked complete, only if all tasks are completed. Our benchmark for success is for at least 4 of the 6 study visits to be completed by each participants
Adherence to Supplement Intake (estimated using unused portion of supplements)	2 years	This outcome will be measured by participants' adherence to the prescribed regiments. At each visit the between-study-visit intake of fish oil, probiotics/ placebo will be; estimated by what remains unused in the original boxes/containers
Adherence to Supplement Intake (Number of missed doses/week)	2 years	Questionnaires detailing intake frequency of the supplements and missed doses will be used in Groups A, B \& C, to assess adherence to prescribed regiments

Secondary Outcome Measures

Name	Time	Method
Study Obstacles (descriptive measures outlining obstacles)	2 years	The actual rate of recruitment, intervention acceptability, completion of study tasks (Dietary intake, EPDS, GAD6, stool collection, lifestyle questionnaires), study visit (\<6 visits) will be compared to the expected rates at the time of study design. All obstacles to attaining the expected rate, will be documented with descriptive measures.

Trial Locations

Locations (1)

Sunnybrook Health Science Center; 🇨🇦 Toronto, Ontario, Canada