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CompletedNCT04472065PACEUpdated Oct 25, 2023

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

An interventional study of Lactobacillus reuteri and Placebo in Mental Health Wellness, sponsored by Elizabeth Austen Lawson. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by Elizabeth Austen Lawson · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Mental Health Wellness

Keywords

  • Gut microbiome
  • Postpartum depression
  • Oxytocin
  • Socio-emotional functioning
  • Probiotic
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Subjects receiving Probiotic Dietary Supplement

    Dietary Supplement: Lactobacillus reuteri

  • Placebo comparator
    Subjects receiving Placebo

    Other: Placebo

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.

05

What researchers measure

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

    Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB).

    Time frame: 6 week

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

06

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
07

Registry details

Key details

Study ID
NCT04472065
Lead sponsor
Elizabeth Austen Lawson
Responsible party
Elizabeth Austen Lawson (Elizabeth A. Lawson, M.D., M.M.Sc., Massachusetts General Hospital) — Sponsor-investigator
First posted
Jul 15, 2020
Start date
Mar 10, 2021
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023
Last update
Oct 25, 2023

Study contacts

Elizabeth A Lawson, MD, MMSc
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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