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Probiotic
Subjects receiving Probiotic Dietary Supplement for Mental Health Wellness (PACE Trial)
N/A
Waitlist Available
Led By Elizabeth A Lawson, MD, MMSc
Research Sponsored by Elizabeth Austen Lawson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 week
Awards & highlights
PACE Trial Summary
This trial is testing whether a probiotic can help improve the wellbeing of new mothers.
PACE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a history of depression or postpartum depression, or your prenatal depression screening score is 8 or higher.
PACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group
Secondary outcome measures
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
Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group
PACE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Subjects receiving Probiotic Dietary SupplementActive Control1 Intervention
Group II: Subjects receiving PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Elizabeth Austen LawsonLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Elizabeth A Lawson, MD, MMScPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
40 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in the clinical trial?
"Yes, as per the details on clinicaltrials.gov, this research project is currently recruiting patients who meet its criteria. It was initially posted on March 10th 2021 and recently modified in April 28 2022. The study seeks to enroll 76 participants from a single medical centre."
Answered by AI
Is this trial accepting participants at the present time?
"Affirmative. According to the information shared on clinicaltrials.gov, recruitment for this trial is ongoing. It was first posted on March 10th 2021 and updated most recentlyon April 28th 2022; 76 patients are expected to be recruited from one site location."
Answered by AI
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