Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

The Canadian College of Naturopathic Medicine

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Perinatal Depression; PerinatalAnxiety

Treatments: Dietary Supplement: Fish oil; Dietary Supplement: Probiotics; Behavioral: Prebiotics; Behavioral: Diet Quality

Study type: Interventional

Funder types: Other

Identifiers

NCT06074250

CCNMREB049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Gutopia

Experimental group

Description:

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.

Treatment:

Behavioral: Prebiotics

Dietary Supplement: Probiotics

Dietary Supplement: Fish oil

Gutboost

Experimental group

Description:

Women in this arm will receive a daily probiotic and fish oil supplement from the time of enrollment till 1 year postpartum.

Treatment:

Dietary Supplement: Probiotics

Dietary Supplement: Fish oil

Gutless

Experimental group

Description:

Women in this arm will receive fish oil and placebo probiotic from the time enrollment till 1 year postpartum .

Treatment:

Dietary Supplement: Fish oil

Gutnone

Active Comparator group

Description:

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.

Treatment:

Behavioral: Diet Quality