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Recruiting NCT07076849

Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females

Phase II Interventional Iron Deficiency (ID) Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactiplantibacillus plantarum 299v, Placebo Capsule(s).
Who it may be relevant to
Registry conditions: Iron Deficiency (ID), Pregnancy. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 supplement Lactiplantibacillus plantarum 299v
    Probiotic
  • Other Placebo Capsule(s)
    Placebo control

Primary outcome measures

  • Maternal hemoglobin from complete blood count (CBC) with differential [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
Secondary outcome measures (12)
  • Maternal iron deficiency anemia (IDA) [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • 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) [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal serum ferritin [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal serum iron [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal sTfR [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal total body iron (TBI) [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal hepcidin [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal erythropoietin (EPO) [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal circulating cytokines (interleukin-6 (IL-6), GM-CS, IL-2, IL-4, IL-8, IL-10, TNFα, and IFNγ [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal C-reactive protein (CRP) [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • Maternal Erythroferrone (ERFE) [Time frame: 10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)]
  • 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) [Time frame: delivery]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Illinois at Chicago — Chicago

Identifiers

NCT: NCT07076849 · 2025-0431

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗