Mental Health Wellness
Conditions
Keywords
Gut microbiome, Postpartum depression, Oxytocin, Socio-emotional functioning, Probiotic
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. 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.
Interventions
DIETARY_SUPPLEMENTLactobacillus 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.
OTHERPlacebo
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.
Sponsors
Elizabeth Austen Lawson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group | 6 week | Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB). |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed