Mental Health WellnessPACENCT04472065
Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being
A study testing Lactobacillus reuteri in people with Mental Health Wellness, run by Elizabeth Austen Lawson at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- Lactobacillus reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 16 Oct 2023
- Phase
- Interventional
- 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
Who may be able to join
- Able and willing to give written informed consent
- Expectant mothers with singleton infant or mothers who have recently given birth to a singleton infant
- At least 18 years of age
- 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
Who cannot join
- Has active substance abuse in the past 6 months or a history of opioid use disorder
- Has diabetes mellitus except for diet controlled gestational diabetes
- Has uncontrolled thyroid disease
- Has inflammatory gastrointestinal disease
- Has active suicidal ideation
- Has a history of psychosis
Show all 13Show fewer
- Has a history of an autism spectrum disorder
- Plans to take other probiotics (other than study product) during study participation
- Plans to take systemic hormonal contraception during study participation (Note: intra-uterine device is allowed)
- Is receiving any systemically administered immunosuppressant medication on a chronic basis
- Has a clinically significant or uncontrolled concomitant illness or condition that would put the subject at risk or jeopardize the objectives of the study
- Has a contraindication, sensitivity, or known allergy to any ingredient of the study product
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
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.
- Conditions
- Mental Health Wellness
- Being tested
- Lactobacillus reuteri, Placebo
- Keywords
- Gut microbiome, Postpartum depression, Oxytocin, Socio-emotional functioning, Probiotic
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving Probiotic Dietary Supplement | Active comparator | Not described Receives: Dietary Supplement: Lactobacillus reuteri |
| Subjects receiving Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 week
Secondary outcomes (2)
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
Measured: Baseline to Week 6
Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start10 Mar 2021
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Expectant mothers who meet eligibility criteria will be randomized 1:1, stratified by C-section or vaginal delivery, to either the probiotic dietary supplement group or the placebo group and will be blinded to treatment assignment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Austen Lawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, MMSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472065
- Sponsor's protocol ID
- 2020P000562
- Acronym
- PACE
- Status last verified
- Oct 2023
- First submitted
- 10 Jul 2020
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Becetti I, Lamont H, Dysart L, Asanza E, Tolley C, Holman K, Mitchell C, Dekel S, Hadjikhani N, Lee H, Ravichandran CT, Carter CS, Kingsbury MA, Erdman SE, Plessow F, Lawson EA. Rationale, design, and statistical analysis plan for a randomized, double-blind, placebo-controlled trial of Limosilactobacillus reuteri to support mother-infant bonding and maternal socioemotional functioning in postpartum women at increased risk for postpartum depression. Contemp Clin Trials. 2026 Jul 3;168:108399. doi: 10.1016/j.cct.2026.108399. Online ahead of print.
PubMed 42398703
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04472065
- Acronym / sponsor ID
- PACE / 2020P000562
- Conditions
- Mental Health Wellness
- Keywords
- Gut microbiome, Postpartum depression, Oxytocin, Socio-emotional functioning, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Elizabeth Austen LawsonUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 15 Jul 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Expectant mothers who meet eligibility criteria will be randomized 1:1, stratified by C-section or vaginal delivery, to either the probiotic dietary supplement group or the placebo group and will be blinded to treatment assignment.
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving Probiotic Dietary Supplement | Active comparator | Dietary Supplement: Lactobacillus reuteri |
| Subjects receiving Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to give written informed consent
- Expectant mothers with singleton infant or mothers who have recently given birth to a singleton infant
- At least 18 years of age
- 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
Key exclusion criteria (13 listed)
- Has active substance abuse in the past 6 months or a history of opioid use disorder
- Has diabetes mellitus except for diet controlled gestational diabetes
- Has uncontrolled thyroid disease
- Has inflammatory gastrointestinal disease
- Has active suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri1 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. | Dietary supplement | Subjects receiving Probiotic Dietary Supplement |
| Placebo1 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. | Other | Subjects receiving Placebo |
Primary outcome
Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group
Time frame: 6 week
Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB).
2 secondary outcomes
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
Time frame: Baseline to Week 6
Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group
Time frame: Baseline to Week 6
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 25 Oct 2023.
- Derived from this study: PubMed 42398703Becetti I, Lamont H, Dysart L, Asanza E, Tolley C, Holman K, Mitchell C, Dekel S, Hadjikhani N, Lee H, Ravichandran CT, Carter CS, Kingsbury MA, Erdman SE, Plessow F, Lawson EA. Rationale, design, and statistical analysis plan for a randomized, double-blind, placebo-controlled trial of Limosilactobacillus reuteri to support mother-infant bonding and maternal socioemotional functioning in postpartum women at increased risk for postpartum depression. Contemp Clin Trials. 2026 Jul 3;168:108399. doi: 10.1016/j.cct.2026.108399. Online ahead of print.
Related trials for Mental Health Wellness
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Elizabeth A Lawson, MD, MMSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri in people with Mental Health Wellness, run by Elizabeth Austen Lawson 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 13 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 25 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group (time frame: 6 week). 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 NCT04472065, which also lists 1 linked publication.
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 25 Oct 2023.