Recruiting
Phase 2

LP299V

Sponsor:

University of Illinois at Chicago

Code:

NCT07076849

Conditions

Iron Deficiency (ID)

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Lactiplantibacillus plantarum 299v

Placebo Capsule(s)

Study Details

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.

Conditions

Iron Deficiency (ID)

Pregnancy

Study ID

NCT07076849

Start date

Feb 1, 2026

Status verified date

Apr, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Oct 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lactiplantibacillus plantarum 299v (LP299V®)

Probiotic

placebo comparator: Control

Placebo capsule

Interventions

Lactiplantibacillus plantarum 299v

Probiotic

Placebo Capsule(s)

Placebo control

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Mary Dawn Koenig, PhD, RN, CNM

312-996-7982marydh@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Tory deMartelly, MPH

3123555119vdemar2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-05-01.