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NCT07076849 · ClinicalTrials.gov registry record · Phase 2
Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females
A Phase 2 study, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT07076849 is a Phase 2 study that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 250 participants.
The verdict
NCT07076849, a Phase 2 study, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study 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 com
Interventions
- OTHER Placebo Capsule(s)
- DIETARY_SUPPLEMENT Lactiplantibacillus plantarum 299v
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2026-02-01 |
| Est. Completion | 2030-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07076849
The ClinicalTrials.gov registry entry for NCT07076849 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Capsule(s) is the first listed.
NCT07076849 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07076849 about?
NCT07076849 is a clinical study titled "Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females". 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 approac...
What is the current status of trial NCT07076849?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2026-02-01. Estimated completion is 2030-11-30.
What interventions are being tested in trial NCT07076849?
The interventions under investigation include: Placebo Capsule(s) (OTHER), Lactiplantibacillus plantarum 299v (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07076849?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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