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Dietary & Supplement Intervention for Perinatal Depression & Anxiety

Phase 2 & 3

Recruiting

Led By Neda Ebrahimi, PhD

Research Sponsored by The Canadian College of Naturopathic Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women 18-43 years old

Be between 18 and 65 years old

Must not have

BMI≥30

Women unwilling to switch to study product(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use diet & supplements to change the microbiome of pregnant women with a history of mood disorders, to reduce the risk and severity of PDA. #GutHealth #MentalHealth

Who is the study for?

This trial is for English-speaking women aged 18-43, in their second trimester of pregnancy, who have a history of depression or anxiety but are currently well. They must be non-smokers and not use alcohol or drugs, and should be financially stable. Women with high BMI, other major mental health disorders, severe medical conditions, allergies to fish oils/supplements ingredients, or those needing chronic antibiotics are excluded.

What is being tested?

The study tests if improving diet quality and adding supplements like prebiotics, probiotics, and fish oil can positively change the gut microbiome to reduce the risk and severity of perinatal depression and anxiety (PDA). Participants will be randomly assigned to one of four groups with different combinations of dietary changes and supplementation.

What are the potential side effects?

Potential side effects may include digestive discomfort from dietary changes or supplements. Fish oil could cause allergic reactions in sensitive individuals. Probiotics might lead to bloating or gas initially as the body adjusts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 43.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is 30 or higher.

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I am unwilling to change my current medication for the study's.

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I struggle to afford basic daily needs like shelter and food.

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I have severe medical conditions like epilepsy or neurological disorders.

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I regularly need antibiotics for a health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Dietary Protocol (Using food frequency questionnaire)

Adherence to Supplement Intake (Number of missed doses/week)

Adherence to Supplement Intake (estimated using unused portion of supplements)

+2 more

Secondary study objectives

Study Obstacles (descriptive measures outlining obstacles)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: GutopiaExperimental Treatment3 Interventions

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 II: GutlessExperimental Treatment1 Intervention

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

Group III: GutboostExperimental Treatment2 Interventions

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

Group IV: GutnoneActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Prebiotics

2008

N/A

~220

Probiotics

2017

Completed Phase 4

~3350