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

Not Applicable

Completed

• Conditions: Mental Health Wellness
• Interventions: Other: Placebo; Dietary Supplement: Lactobacillus reuteri

• Registration Number: NCT04472065
• Lead Sponsor: Elizabeth Austen Lawson

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-15
• Study Start: 2021-03-10
• Status Verified: 2023-10
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects receiving Placebo	Placebo	-
Subjects receiving Probiotic Dietary Supplement	Lactobacillus reuteri	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group	Baseline to Week 6
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States