NCT07076849 Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
| NCT ID | NCT07076849 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Iron Deficiency (ID) |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2030-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2026-02-01 with a primary completion date of 2030-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07076849 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Iron Deficiency (ID). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07076849 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07076849 currently recruiting?
Yes, NCT07076849 is actively recruiting participants. Contact the research team at marydh@uic.edu for enrollment information.
Where is the NCT07076849 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07076849 clinical trial?
NCT07076849 is sponsored by University of Illinois at Chicago. The trial plans to enroll 250 participants.