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

Mental Health Wellness Clinical Trial

— PACE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472065
• Other study ID #: 2020P000562
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: October 16, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Elizabeth Austen Lawson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group		Baseline to Week 6