AUTHOR=Trentini Alessandro , Maritati Martina , Rosta Valentina , Cervellati Carlo , Manfrinato Maria Cristina , Hanau Stefania , Greco Pantaleo , Bonaccorsi Gloria , Bellini Tiziana , Contini Carlo 

TITLE=Vaginal Lactoferrin Administration Decreases Oxidative Stress in the Amniotic Fluid of Pregnant Women: An Open-Label Randomized Pilot Study

JOURNAL=Frontiers in Medicine

VOLUME=7

YEAR=2020

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.00555

DOI=10.3389/fmed.2020.00555

ISSN=2296-858X

ABSTRACT=<p><bold>Background:</bold> Oxidative stress (OxS) has been linked to several pregnancy-related complications. Previous studies demonstrated that lactoferrin (LF) has the ability to modulate inflammation, OxS and the immune function. Therefore, we aimed to observe whether vaginal LF administration was able to decrease OxS in the amniotic fluid (AF) of pregnant women undergoing mid-trimester genetic amniocentesis.</p><p><bold>Methods:</bold> In this open-label clinical study, 60 pregnant women were divided into three groups: CONTROLS (<italic>n</italic> = 20), not treated with LF; LACTO 4HRS (<italic>n</italic> = 20), treated with LF 4 h prior to amniocentesis; LACTO 12HRS (<italic>n</italic> = 20), treated with LF 12 h prior to amniocentesis. Thiobarbituric acid reactive substances (TBARS), total antioxidant status (TAS) and oxidative stress index (OSI) were measured in AF samples. In addition, the <italic>in vitro</italic> antioxidant activity of LF on a cell line was tested.</p><p><bold>Results:</bold> LF decreased the concentration of TBARS in the AF, with LACTO 4HRS demonstrating the lowest value compared with CONTROLS (<italic>P</italic> &lt; 0.0001). LACTO 4HRS had higher TAS and lower OSI than CONTROLS (<italic>P</italic> &lt; 0.0001 for both). <italic>In vitro</italic>, LF was effective against the oxidative challenge regardless of the time of pretreatment.</p><p><bold>Conclusion:</bold> In conclusion, LF decreased both <italic>in vivo</italic> and <italic>in vitro</italic> OxS. LF administration may represent an intriguing clinical solution as an adjuvant to treat complications of pregnancy related to inflammation and OxS.</p><p><bold>Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="https://Clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">Clinicaltrials.gov</ext-link>, NCT02695563. Registered 01 March 2016—Retrospectively registered, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/show/NCT02695563" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/show/NCT02695563</ext-link>.</p>