A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
Condition: Iron-deficiency; Pregnancy, High Risk; Stress, Psychological
MeSH terms: Iron Deficiencies; Stress, Psychological
Study type: Interventional

Summary: 
      The goal of this randomized supplementation feasibility trial is to learn about the
      feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v),
      in pregnant individuals at-risk for iron deficiency anemia.

      The main questions it aims to answer are:

        -  Is daily oral Lp299v a feasible and tolerable intervention for pregnant individuals to
           uptake?

        -  Does daily oral Lp299v in pregnancy impact maternal and neonatal cord hematological and
           iron status parameters?

      Participants will be randomly assigned to one of two treatment groups: daily intake or
      probiotic Lp299v + prenatal vitamin with iron or placebo + prenatal vitamin with iron from
      15-20 weeks of gestation through delivery.

      Researchers will compare the two treatment groups to see if there is a difference in the
      feasibility of the intervention and the preliminary efficacy on maternal and neonatal cord
      hematological and iron status parameters.
    

Detailed description: 
      The most prevalent micronutrient deficiency in the United States (U.S.) is iron; a large
      majority of cases of iron deficiency (ID) and iron deficiency anemia (IDA) occur among
      pregnant women. During pregnancy, maternal iron stores are used for the growing fetus,
      maternal red blood cell (RBC) expansion, and placental growth and development, thus
      increasing the risk for ID and IDA. Across all trimesters of pregnancy in the U.S., it is
      estimated that 18% of individuals have ID and 5% have IDA, and within the third trimester,
      the prevalence of ID exceeds 27%. Prevalence of IDA is even greater among those who identify
      as Black or low-income. Maternal ID and IDA are associated with increased risk of preterm
      birth, low infant birth weight, maternal and fetal mortality, and irreversible infant
      neurocognitive defects. To meet this increasing requirement for iron and to optimize maternal
      iron nutrition, the Recommended Dietary Allowance for pregnancy is 27 mg/day of iron.
      However, given the continued high rates of maternal ID and IDA and only modest adherence to
      daily prenatal vitamins containing iron, alternative approaches to optimizing iron nutrition
      in pregnancy are needed.

      Research has shown that one-time or short-term dosing of the probiotic Lactobacillus
      plantarum 299v (Lp299v) enhances iron absorption in non-pregnant populations. However, few
      studies have examined the effect of long-term supplementation on body iron stores. While
      probiotics are considered safe to consume in pregnancy, only one Lp299v supplementation trial
      has been conducted during the gestational period to evaluate its effects on maternal iron
      stores and risk of IDA. This study, among iron-sufficient pregnant Swedish women, showed a
      significantly lower decline in iron stores and a significantly lower prevalence of IDA in the
      third trimester among those randomized to Lp299v compared to standard care control.

      These results offer potential positive effects for the role of Lp299v in maintaining maternal
      iron status among those starting pregnancy with sufficient iron stores and who receive care
      in a decentralized publicly funded healthcare system. However, no studies have evaluated the
      effect of Lp299v on maternal iron status among individuals at risk for IDA in pregnancy in
      the U.S., nor have studies extended findings to neonatal iron status. Moreover, it is unknown
      if positive feasibility and preliminary efficacy would persist in a U.S.-based health care
      setting with racially, ethnically, and socioeconomically diverse pregnant individuals.
      Therefore, the objectives of this study were as follows. First and foremost, we examined the
      feasibility of daily oral Lp299v maternal supplementation taken from the early second
      trimester through birth. Second, we explored the preliminary efficacy of Lp299v intake on
      maternal (at-risk for IDA defined as hemoglobin (Hb) between 10.0-12.0 g/dL) and neonatal
      cord hematological and iron status parameters compared to controls in an urban U.S. academic
      medical center with a racially, ethnically, and socioeconomically diverse patient population.
    

Intervention name(s): Probiotic LP299v 10x10 colony forming units in capsule form; Placebo in capsule form
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form; Daily placebo in capsule form
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pregnancy; iron status; structural violence