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Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females

Mechanistic Pathways of Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females at Risk of Iron Deficiency Anemia

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07076849
Acronym
ProMoms
Enrollment
250
Registered
2025-07-22
Start date
2026-01-31
Completion date
2030-11-30
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency (ID), Pregnancy

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTLactiplantibacillus plantarum 299v

Probiotic

Placebo control

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* singleton naturally conceived pregnancy; * at risk of IDA \[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; * 18 - 45 years old; * 10-16 weeks GA; * fluency in English to provide consent and complete study procedures; * ability to provide consent; * and ownership of a smartphone (currently more than 90% of our patient population at the CWH).

Exclusion criteria

* IDA or other nutritional anemia (i.e., diagnosed or suspected B12 or folate deficiency) based on new OB blood work that includes MCV and MCH to characterize the anemia; * recent blood transfusion; * autoimmune disorder (e.g., rheumatoid arthritis); * inflammatory bowel disease; * oral or IV antibiotic use within 2 months; * previous spontaneous preterm birth; * history of bariatric surgery; * malabsorptive disease; * current hyperemesis; * current eating disorder; * hematologic disorder or trait carrier (e.g., hemochromatosis, β-thalassemia); * current tobacco, alcohol or illicit drug use (Excluding marijuana).

Design outcomes

Primary

MeasureTime frameDescription
Maternal hemoglobin from complete blood count (CBC) with differential10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw

Secondary

MeasureTime frameDescription
Maternal Erythroferrone (ERFE)10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Fecal abundance of A. muciniphila10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Quantitative polymerase chain reaction (qPCR)
Shot-gun sequencing and analysis (taxonomy and functional profiling)10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)MetaPhlAn4 and HUMAnN 2.0
Microbial mucin degrading enzymes10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)CaZymes
Stool pH10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)pH probe
Adverse pregnancy outcomes post-treatment and at delivery (clinical- EMR)deliveryAdverse pregnancy outcomes post-treatment and at delivery (clinical-EMR)
Probiotic acceptance and tolerability10-16 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 GADaily capsule adherence Reported adverse health effects
Auditory Brainstem Response (ABR) testing-3 days postpartumInterpeak latency I-V
Maternal circulating cytokines (interleukin-6 (IL-6), GM-CS, IL-2, IL-4, IL-8, IL-10, TNFα, and IFNγ10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal serum iron10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal sTfR10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal total body iron (TBI)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)
Maternal hepcidin10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal erythropoietin (EPO)10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal iron deficiency anemia (IDA)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
Complete blood count (CBC) with differential (WBC, RBC, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV and Differential (Absolute and Percent - Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal serum ferritin10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal C-reactive protein (CRP)10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)Venous blood draw
Maternal Erythroferrone (ERFE) Cord Complete blood count (CBC) with differential (WBC, RBC, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV and Differential (Absolute and Percent - Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)deliveryCord blood draw
Cord serum ferritindeliveryCord blood draw
Cord serum irondeliveryCord blood draw
Cord sTfRdeliveryCord blood draw
Cord total body iron (TBI)delivery(TBI (mg/kg) = - \[log(TfR/ferritin ratio) - 2.8229\]/0.1207)
Newborn heel stickAfter delivery before baby released homeBlood spot
Placenta iron transporter (FPN-1 and TFR-1)deliveryWestern blot
Placenta iron quantificationdeliveryImmunohistochemistry
Placenta tissue iron concentrationdeliveryInductively coupled plasma-mass spectrometry (ICP-MS)

Other

MeasureTime frameDescription
Infant characteristics (clinical-EMR)deliveryInfant sex, weight, gestational age (clinical-EMR)
Pre-pregnancy body mass index (BMI)Up to 6 months before pregnancySelf-report (confirmed by clinical-EMR, if possible) BMI will be calculated as kg/m2
Gestational weight gain10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)Gestational weight gain
Gut microbiome factors10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)Questionnaire related to allergies, diet, travel, and environment
Presence of probiotic strain in stool10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)Quantitative polymerase chain reaction (qPCR)
Habitual and recent dietary intake10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)Food frequency (baseline only) questionnaire and 24-hour diet recall
Physical activity10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)Self-report questionnaire

Contacts

Primary ContactMary Dawn Koenig, PhD, RN, CNM
marydh@uic.edu312-996-7982

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026