Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Official title

Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial

Overview

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.

Interventions

• Dietary supplement Fish oil
  1500mg EPA +1000mg DHA daily
• Dietary supplement Probiotics
  Combination strain of lactobacillus and bifidobacteria
• Behavioral Prebiotics
  Dietary consult with follow-up to ensure target fiber intake is met.
• Behavioral Diet Quality
  one time dietary consult at enrollment to discuss strategies to improve overall diet.

Primary outcome measures

• Feasibility of participant recruitment [Time frame: 20 months]
• Adherence to Supplement Intake (estimated using unused portion of supplements) [Time frame: 2 years]
• Adherence to Supplement Intake (Number of missed doses/week) [Time frame: 2 years]
• Adherence to Dietary Protocol (Using food frequency questionnaire) [Time frame: 2 years]
• Completion of Study visits(Number of studies with completed tasks) [Time frame: 2 years]

Secondary outcome measures (1)

• Study Obstacles (descriptive measures outlining obstacles) [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Canada · 1 center

• Sunnybrook Health Science Center — Toronto

Publications

• Gallant F, Cooley K, Grigoriadis S, Ebrahimi N. Targeting maternal gut microbiome to improve mental health outcomes-a pilot feasibility trial. Front Psychiatry. 2024 Aug 7;15:1414291. doi: 10.3389/fpsyt.2024.1414291. eCollection 2024. PMID 39171074

Identifiers

NCT: NCT06074250 · CCNMREB049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗