Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT04472065
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 week
Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB).
Time frame: Baseline to Week 6
Time frame: Baseline to Week 6
Elizabeth Austen Lawson
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT05595486
Behavior, COVID-19
Chicago, Illinois, United States
View Trial DetailsNCT03856931
Behavior, Behavioural Problem
Toronto, Ontario, Canada
View Trial DetailsNCT05760001
Behavior, Behavioral Symptoms
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT05197595
Behavior, Mental Health Wellness
Zaragoza, Spain
View Trial Details