Feasibility and Preliminary Efficacy of Lactobacillus 299v on Maternal and Infant Iron Status Parameters

Abstract Background: Iron deficiency anemia (IDA) is the most prevalent form of anemia in pregnant women world-wide and is associated with adverse maternal and fetal health outcomes. Women that begin pregnancy iron deficient are at an increased risk of maternal and neonatal IDA, however the probiotic Lp299v has been shown to increase iron absorption in non-pregnant populations. Studies are needed to investigate the effects of Lp299v on iron status in pregnant women at increased risk for IDA. Objective: The aims of this randomized placebo-controlled pilot study were to evaluate the effects of Lp299v supplementation on feasibility and tolerability in pregnancy, and to examine its effects on maternal and neonatal hematological iron parameters and iron status in pregnant women at increased risk of IDA. Methods: A total of 21 pregnant women with low-iron stores were randomized at ≥ 20 weeks’ gestation (WG) to receive Lp299v + Prenatal Vitamin with iron (PNVI) or placebo + (PNVI) once daily through labor and delivery. Participant iron related hematological biomarkers, gastrointestinal (GI) symptoms and adverse events (AEs) data were collected at baseline, 24-28 WG, 34-36 WG and Labor and Delivery (L&D), and neonatal iron related hematological biomarkers were collected at L&D only. Results: Supplementation with Lp299v was well tolerated. The prevalence of AEs and GI symptoms were comparable between groups with a feasibility below expected level resulting from lower than projected study recruitment and retention. Based on a per protocol analysis, women with consuming Lp299v had a lower decline in hematological and iron status parameters compared to women in the placebo group. Neonatal hematological and iron status parameters were similar among the probiotic and placebo groups based on the per protocol analysis. Conclusion: Lp299v supplementation in pregnant women with low-iron stores was well tolerated and displayed a positive effect on maternal and neonatal iron related hematological parameters and iron status.