Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome
Key facts
- Who runs it
- The Canadian College of Naturopathic Medicine
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 100 people, planned
- Started
- 15 Aug 2024
- Expected to end
- Mar 2028
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Fish oil
- Probiotics
- Prebiotics
- Diet Quality
- Record updated
- 27 August 2024
Who can take part
- Age
- 18 years to 43 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Cigarette, alcohol and recreational drug users
- 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
- Multiparous women with young children (i.e. one or more children less than 4 years of age at the time of delivery)
- Body Mass Index (BMI)≥30
- Low income (unable to afford basic daily needs (i.e., shelter, food, etc.)
- Having a child with significant mental/physical disability
- Single mothers without any kind of family support,
- Women unwilling to switch to study product(s)
- Non-English Readers/Speakers
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 43 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- GutopiaTreatment being tested
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: Fish oil, Probiotics, and Prebiotics
- GutboostTreatment being tested
Women in this arm will receive a daily probiotic and fish oil supplement from the time of enrollment till 1 year postpartum.
Treatment: Fish oil and Probiotics
- GutlessTreatment being tested
Women in this arm will receive fish oil and placebo probiotic from the time enrollment till 1 year postpartum .
Treatment: Fish oil
- GutnoneExisting treatment, for comparison
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: Diet Quality
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial
- Fit questions
- Built from NCT06074250, who can take part
- Record updated
- 27 August 2024