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Completed

NCT Number: NCT04472065

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Elizabeth Austen Lawson

Other

Registry information

Official study 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

Acronym: PACE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2020
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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