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

NCT04472065 | Completed

• 1 other identifier: 2020P000562
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness

Keywords

Gut microbiome; Postpartum depression; Oxytocin; Socio-emotional functioning; Probiotic

Outcome Measures

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).

  6 week

Secondary Outcomes (2)

• 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

Study Arms (2)

Subjects receiving Probiotic Dietary Supplement

ACTIVE COMPARATOR

Dietary Supplement: Lactobacillus reuteri

Subjects receiving Placebo

PLACEBO COMPARATOR

Other: Placebo

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.

Subjects receiving Probiotic Dietary Supplement

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.

Subjects receiving Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Austen Lawson: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Elizabeth A Lawson, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Elizabeth A. Lawson, M.D., M.M.Sc.

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: March 10, 2021
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

US (1)