Perinatal DepressionPhase 2/3NCT06074250
Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome
A Phase 2/3 study testing Fish oil, Probiotics and Prebiotics in people with Perinatal Depression and PerinatalAnxiety, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Perinatal Depression, PerinatalAnxiety
- What is being tested?
- Fish oil, Probiotics and Prebiotics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2024to Mar 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Science Center
Toronto, Ontario, M4N 3M5
Neda F Ebrahimi, PhD, 4164981255 ext. 418, nebrahimi@ccnm.edu
Kieran P cooley, ND, 4164981255 ext. 324, nebrahimi@ccnm.edu
About this study
Official title: Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial
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.
Read the 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.
- Conditions
- Perinatal Depression, PerinatalAnxiety
- Being tested
- Fish oil, Probiotics, Prebiotics, Diet Quality
- Keywords
- Gut Microbiome, Gut-Brain Axis, Diet, Omega 3 Fatty acids, Probiotics, Fish Oil, Mental Health disorders, Perinatal Depression and anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
Also called Ecosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)
1500mg EPA +1000mg DHA daily
ProbioticsDietary supplement
Combination strain of lactobacillus and bifidobacteria
PrebioticsBehavioural
Dietary consult with follow-up to ensure target fiber intake is met.
Diet QualityBehavioural
one time dietary consult at enrollment to discuss strategies to improve overall diet.
| Study group | Role | What they receive |
|---|---|---|
| Gutopia | Experimental | 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. Receives: Dietary Supplement: Fish oil; Dietary Supplement: Probiotics; Behavioral: Prebiotics |
| Gutboost | Experimental | Women in this arm will receive a daily probiotic and fish oil supplement from the time of enrollment till 1 year postpartum. Receives: Dietary Supplement: Fish oil; Dietary Supplement: Probiotics |
| Gutless | Experimental | Women in this arm will receive fish oil and placebo probiotic from the time enrollment till 1 year postpartum . Receives: Dietary Supplement: Fish oil |
| Gutnone | Active comparator | 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. Receives: Behavioral: Diet Quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of participant recruitment
Time taken to recruit 100 participants in total and successfully randomize/assign 25 participants per study arm.
Measured: 20 months
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
Measured: 2 years
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
Measured: 2 years
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.
Measured: 2 years
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 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
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Lotte & John Hecht Memorial Foundation
- Responsible party
- Principal investigator, Neda Ebrahimi, The Canadian College of Naturopathic Medicine
- Investigators
- Neda Ebrahimi, PhD, Principal investigator, Canadian College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074250
- Sponsor's protocol ID
- CCNMREB049
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39171074
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06074250
- Acronym / sponsor ID
- CCNMREB049
- Conditions
- Perinatal Depression, PerinatalAnxiety
- Keywords
- Gut Microbiome, Gut-Brain Axis, Diet, Omega 3 Fatty acids, Probiotics, Fish Oil, Mental Health disorders, Perinatal Depression and anxiety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Lotte & John Hecht Memorial Foundation
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gutopia | Experimental | Dietary Supplement: Fish oil, Dietary Supplement: Probiotics, Behavioral: PrebioticsWomen 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. |
| Gutboost | Experimental | Dietary Supplement: Fish oil, Dietary Supplement: ProbioticsWomen in this arm will receive a daily probiotic and fish oil supplement from the time of enrollment till 1 year postpartum. |
| Gutless | Experimental | Dietary Supplement: Fish oilWomen in this arm will receive fish oil and placebo probiotic from the time enrollment till 1 year postpartum . |
| Gutnone | Active comparator | Behavioral: Diet QualityWomen 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. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilAlso: Ecosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)1500mg EPA +1000mg DHA daily | Dietary supplement | Gutboost, Gutless, Gutopia |
| ProbioticsCombination strain of lactobacillus and bifidobacteria | Dietary supplement | Gutboost, Gutopia |
| PrebioticsDietary consult with follow-up to ensure target fiber intake is met. | Behavioural | Gutopia |
| Diet Qualityone time dietary consult at enrollment to discuss strategies to improve overall diet. | Behavioural | Gutnone |
Primary outcome
Feasibility of participant recruitment
Time frame: 20 months
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)
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
Adherence to Supplement Intake (Number of missed doses/week)
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
Adherence to Dietary Protocol (Using food frequency questionnaire)
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.
Completion of Study visits(Number of studies with completed tasks)
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
1 secondary outcome
Study Obstacles (descriptive measures outlining obstacles)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 39171074Gallant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neda Ebrahimi, PhD principal investigator
Canadian College of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fish oil, Probiotics and Prebiotics in people with Perinatal Depression and PerinatalAnxiety, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neda Ebrahimi, PhD (416-498-1255 ext. 418, nebrahimi@ccnm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of participant recruitment (time frame: 20 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.