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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2023-10-16

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.

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Detailed Description

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Conditions

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Mental Health Wellness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomization will be performed by the unblinded study pharmacist. All study staff will be blinded to treatment assignment. The infant will be assigned to the same group as their mother.

Study Groups

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Subjects receiving Probiotic Dietary Supplement

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

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.

Subjects receiving Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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Lactobacillus reuteri

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to give written informed consent
2. Expectant mothers with singleton infant or mothers who have recently given birth to a singleton infant
3. At least 18 years of age
4. 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

1. Has active substance abuse in the past 6 months or a history of opioid use disorder
2. Has diabetes mellitus except for diet controlled gestational diabetes
3. Has uncontrolled thyroid disease
4. Has inflammatory gastrointestinal disease
5. Has active suicidal ideation
6. Has a history of psychosis
7. Has a history of an autism spectrum disorder
8. Plans to take other probiotics (other than study product) during study participation
9. Plans to take systemic hormonal contraception during study participation (Note: intra-uterine device is allowed)
10. Is receiving any systemically administered immunosuppressant medication on a chronic basis
11. Has a clinically significant or uncontrolled concomitant illness or condition that would put the subject at risk or jeopardize the objectives of the study
12. Has a contraindication, sensitivity, or known allergy to any ingredient of the study product
13. 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No