University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Location status: Recruiting
NCT Number: NCT07076849
Maternal iron deficiency (ID) and iron deficiency anemia (IDA) is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal IDA in at-risk women is critical. The standard approach to improving iron status in pregnancy (i.e., oral iron supplements) is suboptimal and gastrointestinal discomforts associated with this approach (i.e., constipation) impairs adherence. The incidence of ID (18%) and IDA (5%) in pregnant populations suggest alternative interventions are needed to optimize iron status in pregnancy. There is increasing evidence that consuming the probiotic Lactoplantibacillus plantarum 299v (LP299V®) can enhance dietary non-heme iron absorption by changes in the composition and metabolic patterns of gut microbiota that reduce intestinal pH, enhance mucin production and favor an anti-inflammatory milieu. This immunomodulatory effect may be important because inflammation stimulates hepatic production of hepcidin, a master regulator of systemic iron homeostasis, which inhibits iron flow into circulation from diet and body stores. Further, the effects of LP299V® may extend to the placenta. The investigators' team showed previously that maternal iron deficiency is associated with changes to placental iron metabolism with more iron sequestered in the placenta and less iron transferring to the fetus. Given its positive effects on maternal iron status, the investigators surmise that LP299V® supplementation will result in higher placenta protein expression of iron transporters, transferrin receptor-1 and ferrroportin-1, and lower placental iron accumulation/content. The primary goal of this study is to test the efficacy of this low-cost, safe, innovative approach to optimizing maternal iron status in individuals at risk for ID in pregnancy [Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR] from 10-16 weeks gestational age (GA) until the time of labor. The investigators will also test the effects on neonatal (cord blood) iron status and (cord blood + newborn heel stick) Hb at birth and determine the effect of maternal LP299V® supplementation on the maternal gut microbiome, hepcidin-ferroportin axis and placenta iron and placenta transport of iron as its primary mechanisms of action. Finally, the investigators will explore the effect of maternal LP299V® supplementation on infant neurodevelopment at birth. This study is an essential first step toward evaluating if twice daily oral LP299V® is an efficacious, safe, inexpensive, and scalable clinical strategy for the prevention of maternal ID and its related complications in at-risk women.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Phase 2
Chicago, Illinois, 60612, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotic
Placebo control
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Hb <10.5 g/dL during second trimester and Hb <11 g/dL during third trimester
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
(TBI (mg/kg) = - [log(TfR/ferritin ratio) - 2.8229]/0.1207)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Venous blood draw
Time frame: delivery
Cord blood draw
Time frame: delivery
Cord blood draw
Time frame: delivery
Cord blood draw
Time frame: delivery
Cord blood draw
Time frame: delivery
(TBI (mg/kg) = - [log(TfR/ferritin ratio) - 2.8229]/0.1207)
Time frame: After delivery before baby released home
Blood spot
Time frame: delivery
Western blot
Time frame: delivery
Immunohistochemistry
Time frame: delivery
Inductively coupled plasma-mass spectrometry (ICP-MS)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
Quantitative polymerase chain reaction (qPCR)
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
MetaPhlAn4 and HUMAnN 2.0
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
CaZymes
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
pH probe
Time frame: delivery
Adverse pregnancy outcomes post-treatment and at delivery (clinical-EMR)
Time frame: 10-16 weeks GA, 14-20 weeks GA, 18-24 weeks GA, 22-28 weeks GA, 26-32 weeks GA, 30-36 weeks GA, 34-40 weeks GA, 38-40 weeks GA
Daily capsule adherence Reported adverse health effects
Time frame: -3 days postpartum
Interpeak latency I-V
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Food frequency (baseline only) questionnaire and 24-hour diet recall
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Self-report questionnaire
Time frame: delivery
Infant sex, weight, gestational age (clinical-EMR)
Time frame: Up to 6 months before pregnancy
Self-report (confirmed by clinical-EMR, if possible) BMI will be calculated as kg/m2
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Gestational weight gain
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Questionnaire related to allergies, diet, travel, and environment
Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
Quantitative polymerase chain reaction (qPCR)
Contact information is provided by the study sponsor or research team.
University of Illinois at Chicago
Other
Mechanistic Pathways of Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females at Risk of Iron Deficiency Anemia
Acronym: ProMoms
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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