Depression During PregnancyNCT07227753
The Association Between Gut Microbiota Diversity and Postpartum Depression
An observational study of Depression During Pregnancy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to examine whether naturally occurring bacteria in the gastrointestinal tract are associated with mood changes following childbirth, including postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression During Pregnancy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 8 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Gut Microbiota Diversity and Postpartum Depression： A Prospective Pilot Study
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.
Read the 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.
- Conditions
- Depression During Pregnancy
- Keywords
- depression, postpartum
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 3 days before delivery； within 2 days after delivery
Secondary outcomes (4)
Association between inflammatory cytokines and postpartum depressive symptom severity
Association 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).
Measured: Within 3 days before delivery; within 2 days after delivery
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) will be administered within 3 days before delivery ; within 2 days after delivery; 6 weeks postpartum;
Measured: within 3days before delivery ; within 2 days after delivery; 6 weeks postpartum;
Changes in gut microbiota diversity (alpha and beta)
Alpha 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.
Measured: 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)
Association 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.
Measured: within 3days before delivery ; within 2 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start17 Nov 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression During PregnancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jingping Wang, MD, Ph.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227753
- Sponsor's protocol ID
- 2025P002566
- Other IDs
- 5R21AG081763
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The dataset contains sensitive clinical information from pregnant and postpartum patients at a single institution.
Publications
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.
PubMed 39029663Jin 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.
PubMed 39286351Zhang 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.
PubMed 37160886
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Gut Microbiota Diversity and Postpartum Depression： A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07227753
- Acronym / sponsor ID
- 2025P002566
- Conditions
- Depression During Pregnancy
- Keywords
- depression, postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gut microbiota composition
Time frame: within 3 days before delivery； within 2 days after delivery
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).
4 secondary outcomes
Association between inflammatory cytokines and postpartum depressive symptom severity
Time frame: Within 3 days before delivery; within 2 days after delivery
Edinburgh Postnatal Depression Scale (EPDS; range 0-30; higher scores indicate more depressive symptoms)
Time frame: within 3days before delivery ; within 2 days after delivery; 6 weeks postpartum;
Changes in gut microbiota diversity (alpha and beta)
Time frame: 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)
Time frame: within 3days before delivery ; within 2 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 39029663Sun 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.
- Background: PubMed 39286351Jin 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.
- Background: PubMed 37160886Zhang 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The dataset contains sensitive clinical information from pregnant and postpartum patients at a single institution.
Related trials for Depression During Pregnancy
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain
Not yet recruiting
LLM-Generated Medical Summaries During Hospitalization to Improve Patient Activation in High-Risk Pregnancies
High-risk Pregnancy, Hospitalization
Not yet recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
RecruitingObservational study
Women's Reproductive Choices and Mental Health During Pregnancy and After Birth in Wartime Ukraine
Perinatal Mental Health, Reproductive Behavior
Active, not recruiting
A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression
Depression, Antenatal Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression During Pregnancy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota composition (time frame: within 3 days before delivery； within 2 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07227753, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.