Clinical trial NCT06074250: Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome
Official title: Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Perinatal Depression
PerinatalAnxiety
Keywords: Gut Microbiome
Gut-Brain Axis
Diet
Omega 3 Fatty acids
Probiotics
Fish Oil
Mental Health disorders
Perinatal Depression and anxiety
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Lotte & John Hecht Memorial Foundation
First posted: 2023-10-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of participant recruitment
timeFrame: 20 months
measure: Adherence to Supplement Intake (estimated using unused portion of supplements)
timeFrame: 2 years
measure: Adherence to Supplement Intake (Number of missed doses/week)
timeFrame: 2 years
measure: Adherence to Dietary Protocol (Using food frequency questionnaire)
timeFrame: 2 years
measure: Completion of Study visits(Number of studies with completed tasks)
timeFrame: 2 years
Secondary outcomes:
measure: Study Obstacles (descriptive measures outlining obstacles)
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Science Center
state: Ontario
Study officials:
affiliation: Canadian College of Naturopathic Medicine
name: Neda Ebrahimi, PhD
role: PRINCIPAL_INVESTIGATOR
References: