A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Black Women



Status:Recruiting
Conditions:Psychiatric, Anemia
Therapuetic Areas:Hematology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:1/13/2019
Start Date:November 19, 2018
End Date:June 30, 2019
Contact:Nefertiti Hemphill, MS
Email:ojinjide@uic.edu
Phone:(312) 355-3895

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Mitigating the Effects of Structural Violence on Maternal Iron Status: a Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Black Women

Maternal iron deficiency (ID) and adverse maternal-infant health outcomes disproportionately
affect Black women. Chronic exposure to structural violence can dysregulate a Black woman's
stress response promoting systemic inflammation. Stress-induced inflammation can negatively
affect iron metabolism and promote ID that compromises the health of pregnant women and their
infants - a phenomenon that may explain maternal-infant health disparities in Black women.
Thus, interventions that can mitigate the physiologic effects of chronic stress have the
potential to improve maternal-infant iron status that translates to positive maternal-infant
health outcomes. There is evidence that the probiotic LP299v can reduce the adverse
physiologic effects of stress and normalize iron metabolism although, this has not been
tested in the context of pregnancy. The investigators will conduct a double blinded
placebo-controlled randomized pilot study to determine the feasibility and tolerability of
daily oral LP299v supplementation (15 weeks gestation - delivery) in 20 pregnant Black women
from marginalized neighborhoods of Chicago and explore the effect of daily oral LP299v vs.
placebo on maternal stress response and iron status, infant iron status at delivery, and
molecular mechanisms (maternal microbiome) that may mediate the effect of LP299v on maternal
stress- and iron-related outcomes.


Inclusion Criteria:

- reside in Chicago zip codes: 60612, 60619, 60620, 60624, 60637, 60620, 60644, 60651,
and 60636

- a 1st trimester hemoglobin (Hb) of 10.0 - 11.5 g/dl demonstrating ID or risk for
prenatal ID

- singleton

- naturally conceived pregnancy

- < 15 weeks gestation

- self identify as Black

- 18 - 45 years of age

- sufficient fluency in English to complete study forms

- refrain from non-study dietary and pre-/probiotic supplements while enrolled in the
study

Exclusion Criteria:

- live birth or another pregnancy in the previous 12 months

- oral antibiotic use within the past 2 months

- requiring a separate iron supplement beyond a standard prenatal vitamin

- autoimmune disease

- current or previous premature rupture of membranes/chorioamnionitis

- infection

- receiving steroid treatment

- bariatric surgery

- inflammatory bowel disease

- hyperemesis

- hematologic disorder (e.g., sickle cell disease)

- current tobacco use

- substance abuse in the last 6 months

- other chronic disorders such as type 2 diabetes
We found this trial at
1
site
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Phone: 312-996-7942
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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