Recruiting
Phase 2
Phase 3

PDA & Microbiome

Sponsor:

The Canadian College of Naturopathic Medicine

Code:

NCT06074250

Conditions

Perinatal Depression

PerinatalAnxiety

Eligibility Criteria

Sex: Female

Age: 18 - 43

Healthy Volunteers: Not accepted

Interventions

Fish oil

Probiotics

Prebiotics

Diet Quality

Study Details

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.

Conditions

Perinatal Depression

PerinatalAnxiety

Study ID

NCT06074250

Start date

Aug 15, 2024

Status verified date

Aug, 2024

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 43

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Gutopia

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.

experimental: Gutboost

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

experimental: Gutless

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

active comparator: Gutnone

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.

Interventions

Fish oil

1500mg EPA +1000mg DHA daily

Probiotics

Combination strain of lactobacillus and bifidobacteria

Prebiotics

Dietary consult with follow-up to ensure target fiber intake is met.

Diet Quality

one time dietary consult at enrollment to discuss strategies to improve overall diet.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Neda Ebrahimi, PhD

416-498-1255nebrahimi@ccnm.edu

Sophie Grigoriadis, MD

416-480-5677sophie.grigoriadis@sunnybrook.ca

Locations

Sunnybrook Health Science Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Neda F Ebrahimi, PhD

4164981255nebrahimi@ccnm.edu

Kieran P cooley, ND

4164981255nebrahimi@ccnm.edu

Principal Investigator:

Sophie Grigoriadis, MD

More Information

Sponsor

The Canadian College of Naturopathic Medicine

Last update posted

Aug 27, 2024

Last verified

Aug, 2024

Keywords

  • Gut Microbiome
  • Gut-Brain Axis
  • Diet
  • Omega 3 Fatty acids
  • Probiotics
  • Fish Oil
  • Mental Health disorders
  • Perinatal Depression and anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Canadian College of Naturopathic Medicine on 2024-08-27.