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Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females

RecruitingPhase 2Ages 18 Years - 45 YearsFemaleUniversity of Illinois at Chicago
NCT07076849 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 (LP299Vยฎ) can enhance dietary non-heme iron absorption by changes in the composition and metabolic patterns of gut microbiota that reduce intestinal pH, enhance mucin product

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๐Ÿ“‹ Eligibility rules (as published)
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, ฮฒ-thalassemia); * current tobacco, alcohol or illicit drug use (Excluding marijuana).
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What it tests

  • Lactiplantibacillus plantarum 299v
  • Placebo Capsule(s)
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Where

1 site
University of Illinois at Chicago
Chicago, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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