The Association Between Gut Microbiota Diversity and Postpartum Depression

NCT07227753 | Recruiting

• 2 other identifiers: 2025P0025665R21AG081763
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression During Pregnancy

Keywords

depression; postpartum

Outcome Measures

Primary Outcomes (1)

• gut microbiota composition

  Compare 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).

  within 3 days before delivery； within 2 days after delivery

Secondary Outcomes (4)

• Association between inflammatory cytokines and postpartum depressive symptom severity

  Within 3 days before delivery; within 2 days after delivery

• 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;

• Changes in gut microbiota diversity (alpha and beta)

  within 3days before delivery ; within 2 days after delivery

• 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 delivery

Study Arms (2)

High-Edinburgh Postnatal Depression Scale cohort

Pregnant participants with antepartum Edinburgh Postnatal Depression Scale (EPDS; range 0-30; higher scores indicate more depressive symptoms) ≥13. Peripheral venous blood (serum) and rectal swab collected ≤3 days pre-delivery and ≤2 days postpartum; optional 6-week follow-up. Observational only-no interventions assigned.

Low-Edinburgh Postnatal Depression Scale cohort

Pregnant individuals with antepartum Edinburgh Postnatal Depression Scale (EPDS; range 0-30; higher scores indicate more depressive symptoms) \<13; same specimen collection and follow-up schedule as the high-EPDS cohort; no interventions assigned.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants are cisgender women who are pregnant or postpartum. Participants must have been assigned female at birth and currently self-identify as women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years or older, with gestational age of at least 36 weeks, planning either vaginal or cesarean delivery. Individuals with serious digestive disorders, severe mental health conditions, or recent use of medications such as antibiotics or antidepressants that may affect gut bacteria are excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Meikun Wang

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• Sun Y, Fan C, Lei D. Association between gut microbiota and postpartum depression: A bidirectional Mendelian randomization study. J Affect Disord. 2024 Oct 1;362:615-622. doi: 10.1016/j.jad.2024.07.057. Epub 2024 Jul 17.

  PMID: 39029663 BACKGROUND

• Jin W, Li B, Wang L, Zhu L, Chai S, Hou R. The causal association between gut microbiota and postpartum depression: a two-sample Mendelian randomization study. Front Microbiol. 2024 Sep 2;15:1415237. doi: 10.3389/fmicb.2024.1415237. eCollection 2024.

  PMID: 39286351 BACKGROUND

• Zhang Y, Baldyga K, Dong Y, Song W, Villanueva M, Deng H, Mueller A, Houle TT, Marcantonio ER, Xie Z. The association between gut microbiota and postoperative delirium in patients. Transl Psychiatry. 2023 May 9;13(1):156. doi: 10.1038/s41398-023-02450-1.

  PMID: 37160886 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood (\~5 mL; processed to serum and plasma) and rectal swab specimens will be collected around the time of delivery (pre-delivery within 3 days and early postpartum within 2 days). Specimens will be coded, stored at -80 °C, and used for laboratory analyses approved by the Institutional Review Board. No direct identifiers accompany specimens. No human whole-genome sequencing is planned.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jingping Wang, MD PhD

CONTACT

6179369136; jwang23@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 13, 2025
• Study Start: November 17, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)