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

Elizabeth Austen Lawson

Status: Completed

Conditions: Mental Health Wellness

Treatments: Other: Placebo; Dietary Supplement: Lactobacillus reuteri

Study type: Interventional

Funder types: Other

Identifiers

NCT04472065

2020P000562

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Subjects receiving Probiotic Dietary Supplement

Active Comparator group

Treatment:

Dietary Supplement: Lactobacillus reuteri

Subjects receiving Placebo

Placebo Comparator group

Treatment:

Other: Placebo