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

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christiane Tolley, MSN; Phone Number: (617) 724-7216; Email: ctolley@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subjects receiving Probiotic Dietary Supplement	Dietary supplement: Lactobacillus 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.
Placebo Comparator: Subjects receiving Placebo	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Elizabeth Austen Lawson
• Investigators: Principal Investigator: Elizabeth A Lawson, MD, MMSc, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Oxytocin; Probiotic; Postpartum depression; Gut microbiome; Socio-emotional functioning
• Other Study ID Numbers: 2020P000562

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No