---
title: Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being
nct_id: NCT04472065
overall_status: COMPLETED
phase: NA
sponsor: Elizabeth Austen Lawson
study_type: INTERVENTIONAL
primary_condition: Mental Health Wellness
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04472065.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04472065"
ct_last_update_post_date: 2023-10-25
last_seen_at: "2026-05-12T07:18:16.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being

**Official Title:** A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of a Probiotic Dietary Supplement on the Gut Microbiome, Oxytocin Levels, Socio-emotional Functioning, and Well-being in Mother-Infant Dyads

**NCT ID:** [NCT04472065](https://clinicaltrials.gov/study/NCT04472065)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 46
- **Lead Sponsor:** Elizabeth Austen Lawson
- **Conditions:** Mental Health Wellness
- **Start Date:** 2021-03-10
- **Completion Date:** 2023-10-16
- **CT.gov Last Update:** 2023-10-25

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **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
```

## Arms

- **Subjects receiving Probiotic Dietary Supplement** (ACTIVE_COMPARATOR)
- **Subjects receiving Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **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.
- **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.

## Primary Outcomes

- **Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group** _(time frame: 6 week)_ — Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB).

## Secondary Outcomes

- **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** _(time frame: Baseline to Week 6)_
- **Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group** _(time frame: Baseline to Week 6)_

## Locations (1)

- Massachusetts General Hospital, Boston, Massachusetts, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.massachusetts general hospital|boston|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04472065.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04472065*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*