NCT Number: NCT06074250
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.
Interested in participating?
Request Info18 year–43 year
Female
Interventional
Phase 2 / Phase 3
Toronto, Ontario, M4N 3M5, Canada
Location status: Recruiting
Kieran P cooley, ND
CONTACT
4164981255 ext. 324
Neda F Ebrahimi, PhD
CONTACT
4164981255 ext. 418
Sophie Grigoriadis, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1500mg EPA +1000mg DHA daily
Other names: Ecosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)
Combination strain of lactobacillus and bifidobacteria
Dietary consult with follow-up to ensure target fiber intake is met.
one time dietary consult at enrollment to discuss strategies to improve overall diet.
Time frame: 20 months
Time taken to recruit 100 participants in total and successfully randomize/assign 25 participants per study arm.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
The Canadian College of Naturopathic Medicine
Other
Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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