search
Back to results

Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

Primary Purpose

Perinatal Depression, PerinatalAnxiety

Status
Not yet recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fish oil
Probiotics
Prebiotics
Diet Quality
Sponsored by
The Canadian College of Naturopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Depression focused on measuring Gut Microbiome, Gut-Brain Axis, Diet, Omega 3 Fatty acids, Probiotics, Fish Oil, Mental Health disorders, Perinatal Depression and anxiety

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Sunnybrook Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Gutopia

Gutboost

Gutless

Gutnone

Arm Description

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.

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

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

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.

Outcomes

Primary Outcome Measures

Feasibility of participant recruitment
Time taken to recruit 100 participants in total and successfully randomize/assign 25 participants per study arm.
Adherence to Supplement Intake (estimated using unused portion of supplements)
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
Adherence to Supplement Intake (Number of missed doses/week)
Questionnaires detailing intake frequency of the supplements and missed doses will be used in Groups A, B & C, to assess adherence to prescribed regiments
Adherence to Dietary Protocol (Using food frequency questionnaire)
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.
Completion of Study visits(Number of studies with completed tasks)
At each visit participants are expected to provide (1)dietary intake using myfitnesspal, (2) Mental health Scores using EPDS and GAD7 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

Secondary Outcome Measures

Study Obstacles (descriptive measures outlining obstacles)
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.

Full Information

First Posted
August 3, 2023
Last Updated
October 6, 2023
Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Sunnybrook Health Sciences Centre, Lotte & John Hecht Memorial Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT06074250
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Sunnybrook Health Sciences Centre, Lotte & John Hecht Memorial Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, PerinatalAnxiety
Keywords
Gut Microbiome, Gut-Brain Axis, Diet, Omega 3 Fatty acids, Probiotics, Fish Oil, Mental Health disorders, Perinatal Depression and anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gutopia
Arm Type
Experimental
Arm Description
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.
Arm Title
Gutboost
Arm Type
Experimental
Arm Description
Women in this arm will receive a daily probiotic and fish oil supplement from the time of enrollment till 1 year postpartum.
Arm Title
Gutless
Arm Type
Experimental
Arm Description
Women in this arm will receive fish oil and placebo probiotic from the time enrollment till 1 year postpartum .
Arm Title
Gutnone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Other Intervention Name(s)
EPA, DHA
Intervention Description
1500mg EPA +1000mg DHA daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
Combination strain of lactobacillus and bifidobacteria
Intervention Type
Behavioral
Intervention Name(s)
Prebiotics
Intervention Description
Dietary consult with follow-up to ensure target fiber intake is met.
Intervention Type
Behavioral
Intervention Name(s)
Diet Quality
Intervention Description
one time dietary consult at enrollment to discuss strategies to improve overall diet.
Primary Outcome Measure Information:
Title
Feasibility of participant recruitment
Description
Time taken to recruit 100 participants in total and successfully randomize/assign 25 participants per study arm.
Time Frame
20 months
Title
Adherence to Supplement Intake (estimated using unused portion of supplements)
Description
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
Title
Adherence to Supplement Intake (Number of missed doses/week)
Description
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
Title
Adherence to Dietary Protocol (Using food frequency questionnaire)
Description
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
Title
Completion of Study visits(Number of studies with completed tasks)
Description
At each visit participants are expected to provide (1)dietary intake using myfitnesspal, (2) Mental health Scores using EPDS and GAD7 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
Secondary Outcome Measure Information:
Title
Study Obstacles (descriptive measures outlining obstacles)
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neda Ebrahimi, PhD
Phone
416-498-1255
Ext
418
Email
nebrahimi@ccnm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Grigoriadis, MD
Phone
416-480-5677
Email
sophie.grigoriadis@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neda Ebrahimi, PhD
Organizational Affiliation
Canadian College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Science Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neda F Ebrahimi, PhD
Phone
4164981255
Ext
418
Email
nebrahimi@ccnm.edu
First Name & Middle Initial & Last Name & Degree
Kieran P cooley, ND
Phone
4164981255
Ext
324
Email
nebrahimi@ccnm.edu
First Name & Middle Initial & Last Name & Degree
Sophie Grigoriadis, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

We'll reach out to this number within 24 hrs