Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being

Study Overview
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Brief Summary
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Researchers at Massachusetts General Hospital are interested in learning more about the neurobiology of well-being in new mothers and novel ways to support them during their transition to parenthood. This study aims to evaluate well-being in new mothers and their infant and the impact of a probiotic dietary supplement on the gut microbiome. This study hopes to help improve the existing knowledge of maternal postnatal health.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of a Probiotic Dietary Supplement on the Gut Microbiome, Oxytocin Levels, Socio-emotional Functioning, and Well-being in Mother-Infant Dyads

Conditions
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Mental Health Wellness

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Able and willing to give written informed consent Expectant mothers with singleton infant or mothers who have recently given birth to a singleton infant At least 18 years of age At risk for postpartum depression as defined: a hx of depression and/or, a hx of postpartum depression and/or by a prenatal EPDS score ≥ 8 Exclusion Criteria: Has active substance abuse in the past 6 months or a history of opioid use disorder Has diabetes mellitus except for diet controlled gestational diabetes Has uncontrolled thyroid disease Has inflammatory gastrointestinal disease Has active suicidal ideation Has a history of psychosis Has a history of an autism spectrum disorder Plans to take other probiotics (other than study product) during study participation Plans to take systemic hormonal contraception during study participation (Note: intra-uterine device is allowed) Is receiving any systemically administered immunosuppressant medication on a chronic basis Has a clinically significant or uncontrolled concomitant illness or condition that would put the subject at risk or jeopardize the objectives of the study Has a contraindication, sensitivity, or known allergy to any ingredient of the study product Is considered, in the opinion of the Principal Investigator (PI), to likely be a poor attendee or unlikely for any reason to be able to comply with the study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Expectant mothers who meet eligibility criteria will be randomized 1:1, stratified by C-section or vaginal delivery, to either the probiotic dietary supplement group or the placebo group and will be blinded to treatment assignment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subjects receiving Probiotic Dietary Supplement<br> | Dietary Supplement: Lactobacillus reuteri<br>* 1 chewable tablet of probiotic dietary supplement (200 million CFU of L. reuteri DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.<br>|
| Placebo Comparator: Subjects receiving Placebo<br> | Other: Placebo<br>* 1 chewable placebo tablet containing all the same ingredients except L. reuteri (DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group | Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB). | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Toronto Alexithymia Scale (TAS-20) Total Score (range: 20-100; direction: lower scores indicate better socioemotional functioning) in the probiotic versus placebo group |  | Baseline to Week 6 | 
| Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group |  | Baseline to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiome, Postpartum depression, Oxytocin, Socio-emotional functioning, Probiotic