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The Association Between Gut Microbiota Diversity and Postpartum Depression

The Association Between Gut Microbiota Diversity and Postpartum Depression: A Prospective Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07227753
Enrollment
30
Registered
2025-11-13
Start date
2025-11-17
Completion date
2026-04-08
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression During Pregnancy

Keywords

depression, postpartum

Brief summary

This study aims to examine whether naturally occurring bacteria in the gastrointestinal tract are associated with mood changes following childbirth, including postpartum depression. Biological samples will be collected before and after delivery to determine whether specific patterns in gut bacterial composition are linked to emotional states. The purpose of the research is to improve understanding of whether such microbial changes can help identify individuals at higher risk for postpartum depression, enabling earlier recognition and intervention.

Detailed description

This prospective observational pilot study is designed to explore the relationship between gut microbial diversity and depressive symptoms during the early postpartum period. Postpartum depression is one of the most frequent complications after childbirth and has a substantial impact on the physical and psychological well-being of mothers and infants. The study investigates whether differences in gut microbial composition are associated with the development of depressive symptoms following childbirth. Pregnant individuals aged eighteen years or older planning cesarean delivery at Massachusetts General Hospital will be enrolled. Data and biological samples will be collected at two time points: within three days before delivery and within 2 days after delivery. Blood samples will be collected for measurement of inflammatory markers, and rectal swab samples will be obtained to evaluate the composition and diversity of gut microorganisms through metagenomic sequencing. A validated questionnaire assessing emotional state will be administered at the same time points, and a follow-up emotional assessment will be obtained six weeks after childbirth through the electronic medical record system. The study examines microbial characteristics associated with the presence or absence of depressive symptoms and evaluates correlations between microbial community patterns and emotional status, aiming to identify potential microbiome-based biomarkers predictive of early onset depressive symptoms after childbirth. The research does not include drug administration, device testing, or experimental treatment. All procedures are non-invasive or minimally invasive and coincide with routine obstetric care, minimizing participant burden. The results of this study are expected to provide preliminary evidence linking the gut microbial environment to maternal mental health. Findings may inform future strategies for early detection and prevention of postpartum depressive symptoms and support the development of personalized approaches to maternal mental wellness.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Gestational age at least 36 weeks, planned cesarean delivery * Ability to understand study procedures and provide informed consent * Voluntary agreement to participate in the study

Exclusion criteria

* Gastrointestinal disorders or recent antibiotic use that significantly alters gut microbiome * Diagnosis of severe mental illness such as schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with psychotic features * Medication use during pregnancy known to influence gut microbiota, including antidepressants, antibiotics, or fish oil * Refusal to provide rectal swab samples or inability to complete follow-up assessments

Design outcomes

Primary

MeasureTime frameDescription
gut microbiota compositionwithin 3 days before delivery; within 2 days after deliveryCompare gut microbiota composition between participants with postpartum depression (defined as Edinburgh Postnatal Depression Scale (EPDS; range 0-30; higher scores indicate more depressive symptoms) ≥13) and without postpartum depression (EPDS \<13).

Secondary

MeasureTime frameDescription
Association between inflammatory cytokines and postpartum depressive symptom severityWithin 3 days before delivery; within 2 days after deliveryAssociation between serum inflammatory cytokines (e.g., Interleukin-6, Tumor Necrosis Factor-alpha) and depressive symptom severity measured by the Edinburgh Postnatal Depression Scale (EPDS; range 0-30; higher scores indicate more depressive symptoms).
Edinburgh Postnatal Depression Scale (EPDS; range 0-30; higher scores indicate more depressive symptoms)within 3days before delivery ; within 2 days after delivery; 6 weeks postpartum;Edinburgh Postnatal Depression Scale (EPDS; range 0-30; higher scores indicate more depressive symptoms) will be administered within 3 days before delivery ; within 2 days after delivery; 6 weeks postpartum;
Changes in gut microbiota diversity (alpha and beta)within 3days before delivery ; within 2 days after deliveryAlpha diversity (e.g., Shannon, Simpson, observed ASVs) and beta diversity (e.g., Bray-Curtis, UniFrac) will be calculated from rectal swab profiles. Change over time will be compared within participants.
Correlation between relative abundance of selected microbial taxa and maternal depressive symptom severity measured by the Edinburgh Postnatal Depression Scale (EPDS)within 3days before delivery ; within 2 days after deliveryAssociation between the relative abundance of prespecified taxa (e.g., Lactobacillus, Clostridium) from rectal swabs and Edinburgh Postnatal Depression Scale (EPDS; 0-30, higher scores indicate more depressive symptoms) at each timepoint and longitudinally within participants.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026