Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving Probiotic Dietary Supplement | Active Comparator |
| |
| Subjects receiving Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Lawson, MD, MMSc | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42398703 | Derived | Becetti I, Lamont H, Dysart L, Asanza E, Tolley C, Holman K, Mitchell C, Dekel S, Hadjikhani N, Lee H, Ravichandran CT, Carter CS, Kingsbury MA, Erdman SE, Plessow F, Lawson EA. Rationale, design, and statistical analysis plan for a randomized, double-blind, placebo-controlled trial of Limosilactobacillus reuteri to support mother-infant bonding and maternal socioemotional functioning in postpartum women at increased risk for postpartum depression. Contemp Clin Trials. 2026 Jul 3:108399. doi: 10.1016/j.cct.2026.108399. Online ahead of print. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
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.
Not provided
Not provided
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.
| Placebo | 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. |
|
| Baseline to Week 6 |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |