Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females

NCT07076849 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-0431
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maternal hemoglobin from complete blood count (CBC) with differential

  Venous blood draw

  10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)

Secondary Outcomes (27)

• Maternal iron deficiency anemia (IDA)

  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)

  10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)

• Maternal serum ferritin

  10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)

• Maternal serum iron

  10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)

• Maternal sTfR

  10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)

Other Outcomes (7)

• Habitual and recent dietary intake

  10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)

• Physical activity

  10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)

• Infant characteristics (clinical-EMR)

  delivery

Study Arms (2)

Lactiplantibacillus plantarum 299v (LP299V®)

EXPERIMENTAL

Probiotic

Dietary Supplement: Lactiplantibacillus plantarum 299v

Control

PLACEBO COMPARATOR

Placebo capsule

Other: Placebo Capsule(s)

Interventions

Placebo Capsule(s) OTHER

Placebo control

Control

Lactiplantibacillus plantarum 299v DIETARY_SUPPLEMENT

Probiotic

Lactiplantibacillus plantarum 299v (LP299V®)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• years old;
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Mary Dawn Koenig, PhD, RN, CNM

CONTACT

312-996-7982; marydh@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 22, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)