Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome

NCT ID: NCT06074250

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2028-03-31

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.

Conditions

Perinatal Depression; PerinatalAnxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fish oil

Intervention Type: DIETARY_SUPPLEMENT

1500mg EPA +1000mg DHA daily

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Combination strain of lactobacillus and bifidobacteria

Prebiotics

Intervention Type: BEHAVIORAL

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

Gutboost

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

Group Type: EXPERIMENTAL

Fish oil

Intervention Type: DIETARY_SUPPLEMENT

1500mg EPA +1000mg DHA daily

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Combination strain of lactobacillus and bifidobacteria

Gutless

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

Group Type: EXPERIMENTAL

Fish oil

Intervention Type: DIETARY_SUPPLEMENT

1500mg EPA +1000mg DHA daily

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.

Group Type: ACTIVE_COMPARATOR

Diet Quality

Intervention Type: BEHAVIORAL

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

Interventions

Fish oil

1500mg EPA +1000mg DHA daily

Intervention Type: DIETARY_SUPPLEMENT

Probiotics

Combination strain of lactobacillus and bifidobacteria

Intervention Type: DIETARY_SUPPLEMENT

Prebiotics

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

Intervention Type: BEHAVIORAL

Diet Quality

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Ecosapentaenoic Acid (EPA); Docosahexaenoic Acid (DHA)

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Lotte & John Hecht Memorial Foundation

OTHER

Sponsor Role: collaborator

The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Neda Ebrahimi

Head of Microbiome Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neda Ebrahimi, PhD

Role: PRINCIPAL_INVESTIGATOR

Canadian College of Naturopathic Medicine

Locations

Sunnybrook Health Science Center

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Neda Ebrahimi, PhD

Role: CONTACT

nebrahimi@ccnm.edu

416-498-1255 ext. 418

Sophie Grigoriadis, MD

Role: CONTACT

sophie.grigoriadis@sunnybrook.ca

416-480-5677

Facility Contacts

Neda F Ebrahimi, PhD

Role: primary

nebrahimi@ccnm.edu

4164981255 ext. 418

Kieran P cooley, ND

Role: backup

nebrahimi@ccnm.edu

4164981255 ext. 324

References

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.

Reference Type: DERIVED

PMID: 39171074 (View on PubMed)

Other Identifiers

CCNMREB049

Identifier Type: -

Identifier Source: org_study_id