Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Illinois at Chicago

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactiplantibacillus plantarum 299v

    Dietary supplement

    Probiotic

  • Placebo Capsule(s)

    Other intervention

    Placebo control

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Lactiplantibacillus plantarum 299v (LP299V®)Experimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maternal hemoglobin from complete blood count (CBC) with differential

Venous blood draw

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

Secondary outcomes

1

Maternal iron deficiency anemia (IDA)

Hb \<10.5 g/dL during second trimester and Hb \<11 g/dL during third trimester

Time frame
10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
2

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)

Venous blood draw

Time frame
10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
3

Maternal serum ferritin

Venous blood draw

Time frame
10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3), delivery (V4)
4

Maternal serum iron

Venous blood draw

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

Other outcomes

1

Habitual and recent dietary intake

Food frequency (baseline only) questionnaire and 24-hour diet recall

Time frame
10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
2

Physical activity

Self-report questionnaire

Time frame
10-16 weeks GA (V1), 22-28 weeks GA (V2), 30-36 weeks GA (V3)
3

Infant characteristics (clinical-EMR)

Infant sex, weight, gestational age (clinical-EMR)

Time frame
delivery
4

Pre-pregnancy body mass index (BMI)

Self-report (confirmed by clinical-EMR, if possible) BMI will be calculated as kg/m2

Time frame
Up to 6 months before pregnancy

Sponsors and contacts

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