Status:
COMPLETED
Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being
Lead Sponsor:
Elizabeth Austen Lawson
Conditions:
Mental Health Wellness
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04472065
Start Date
March 10 2021
End Date
October 16 2023
Last Update
October 25 2023
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114