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Flow diagram according to the trial protocol.
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Background
Spontaneous preterm deliveries that occur before the 34th week of gestation, and particularly before the 32nd week of gestation, have been strongly associated to intrauterine infection, ascending from vagina, and represent the largest portion of neonatal deaths and neurological problems. Bacterial vaginosis, characterized by a diminished...
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Citations
... Bei Einsatz von Probiotika ist die Patientenakzeptanz im Regelfall sehr gut, da im Vergleich zu Antibiotika kaum Abb.9 8 Etwaige Auswirkungen einer Dysbiose im Genitaltrakt. (Nach[13], with permission from Elsevier) Abb.10 9 Risikoerhöhung für Aborte und intrauterinen Fruchttod bei bakterieller Vaginose.[14,15] und wenn dann nur geringe Nebenwirkungen auftreten.Beieiner randomisierten doppeltblinden Studie von Garcia-Velasco et al. (ASRM, 2018 [16]) wurde Lactobacillus Rhamnosus gezielt vaginal während eines Stimulationszyklus bei 50 Eizellspenderinnen eingesetzt. ...
The human organism consists of approximately a billion body cells, but it is populated with ten times more microorganisms. The entirety of all these microorganisms is referred to as a microbiota. The genome of the microbiota is called a microbiome. Endometrial receptivity studies have demonstrated the existence of an endometrial microbiome. It was found that dysbiosis, a pathological shift of the eubiotic vaginal or uterine flora towards the non-lactobacillus microbiota, can lead to infertility and that the rate of early and late miscarriage as well as the stillbirth rate and premature birth rate increase. Therefore, a healthy microbiome in the female genital tract seems to be important for women’s health and fertility.
... In this study, they administered 2 capsules per day (each capsule containing over 1 million lactobacilli), for 6-12 weeks, up to 24-25 weeks of gestation of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. (14) In the prevention of premature births, we mention progesterone supplementation and transvaginal cervical measurements to establish the maintenance of the pregnancy hormone therapy (vaginal or oral). Calcium supplementation (> 1g/day, respectively 1.2-2g/day in case of low calcium diet) has been associated with a significant reduction in the risk of preeclampsia and premature birth. ...
Gestational hypertension and premature birth frequently and independently affect the pregnancy prognosis with potentially detrimental influence of the pregnancy evolution. Pregnancy-induced hypertension, spectrum and categories of the systemic disease: gestational hypertension, preeclampsia, eclamsia, Hellp syndrome, overlapping preeclampsia (PE) chronic arterial hypertension, are some of the complications that can occur over the pregnancy evolution. Annually, preeclampsia affects approximately 4 million pregnancies. According to ACOG, preeclampsia complicates the evolution of pregnancies in a 2-8% ratio. According to WHO and FIGO, premature birth occurs after 37 weeks of complete amenorrhea (AS) (or 259 days of amenorrhea). A spontaneous premature birth complicates about 5-18% of pregnancies. I emphasize that the two gestational syndromes are intricate because 1/4-1/3 of premature births are associated with preeclampsia. Considered to be an important public health problem, it is important to identify new methods of evaluation, screening and therapy for gestational syndromes, taking into account the risk of increased recurrence of child birth in a subsequent pregnancy.
... Two studies (NCT00217308 and NCT00303082), were designed to test the effect of oral administration of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 or placebo on the incidence of BV and PTB (co-primary outcomes [143]). Both were discontinued due to difficulties with recruitment, but the partial results were published [144]. ...
Preterm birth (PTB) (<37 weeks of gestation) is the leading cause of newborn death and a risk factor for short and long-term adverse health outcomes. Most cases are of unknown cause. Although the mechanisms triggering PTB remain unclear, an inappropriate increase in net inflammatory load seems to be key. To date, interventions that reduce the risk of PTB are effective only in specific groups of women, probably due to the heterogeneity of its etiopathogenesis. Use of progesterone is the most effective, but only in singleton pregnancies with history of PTB. Thus, primary prevention is greatly needed and nutritional and bioactive solutions are a promising alternative. Among these, docosahexaenoic acid (DHA) is the most promising to reduce the risk for early PTB. Other potential nutrient interventions include the administration of zinc (possibly limited to populations with low nutritional status or poor zinc status) and vitamin D; additional preliminary evidence exists for vitamin A, calcium, iron, folic acid, combined iron-folate, magnesium, multiple micronutrients, and probiotics. Considering the public health relevance of PTB, promising interventions should be studied in large and well-designed clinical trials. The objective of this review is to describe, summarize, and discuss the existing evidence on nutritional and bioactive solutions for reducing the risk of PTB.
... Так, в репродуктивном тракте мужчин выявлены Staphylococcus epidermidis, Corynebacterium spp., Lactobacilli, Haemo-philus vaginalis, alpha-hemolytic streptococci [40]. Таким образом, в отличие от женщин репродуктивного возраста, у которых доминирующей группой бактерий в норме являются представители рода Lactobacillus, у мужчин уретральная микробиота в норме не содержит какой-либо один доминирующий микроорганизм, а бактериальные сообщества нормальной микробиоты являются сложными [53]. ...
... Одним из вариантов диарейного синдрома является диарея, ассоциированная с антибиотиками (ААД), которая может быть неинфекционной и инфекционной природы [52,53]. Под воздействием антибиотиков существенно изменяется микробиота пищеварительного тракта. ...
... Уменьшение количества нормальной микробиоты приводит к увеличению нутриентов в толстой кишке, и патогенные микроорганизмы (наиболее часто это K.oxytoca, E.coli 0157:H7, метициллинрезистентные штаммы S.aureus, протей, -энтерококки) начинают активно питаться и размножаться [52]. Одним из наиболее изученных и часто встречающихся микроорганизмов, ассоциированных с ААД, является C.difficile [53]. Лечение ААД необходимо начинать с отмены антибактериального препарата, явившегося ее причиной, как при инфекционной, так и при идиопатической форме. ...
Микробиота человека — это совокупность микробиоценозов, занимающих многочисленные экологические ниши на коже и слизистых оболочках в местах контакта человеческого организма с окружающей средой.
Симбиотическая микробиота играет огромную роль в обеспечении здорового состояния нашего организма. Она защищает от патогенов, поддерживает иммунитет, обеспечивает производство важных компонентов питания. Микробиота человека включает тысячи видов грибов, эубактерий, архей и вирусов. Суммарное количество клеток только эубактерий в составе микробиоты превышает десять триллионов, что в сто раз больше числа собственных клеток организма человека. С развитием науки исследователи получили возможность очень точной и комплексной оценки всего микробного сообщества с глубиной до тысячных долей процента (по содержанию микроба). Это позволило выйти на новый уровень понимания взаимосвязи здоровья человека и состояния его микробиома.
Микробиота является весьма чувствительным индикатором, реагирующим количественными и качественными изменениями на любые сдвиги внешней и внутренней среды [9]. Изменение количественного и качественного состава того или иного вида микроорганизмов в биотопе служит сигналом об адаптивных или необратимых изменениях в соответствующем звене микроэкологической системы [3]. Существует множество факторов, оказывающих негативное воздействие на микробиоту организма, поэтому вопрос о ее восстановлении, коррекции и предупреждении дисбаланса является весьма актуальным.
... Sepsis secondary to prenatal vaginosis is attributed to vertical transmission. Several authors report that all markers of oxidative stress, including IL-6, were higher in the preeclampsia group compared to controls [27]. ...
Background: to determine the relationship and association of early sepsis with interleukin-6 measured in umbilical blood, as well as gestational age and birth weight, prenatal history of the mother pathologies during pregnancy, in full-term newborns at the Neonatology Service of Carlos Andrade Marín Hospital (Quito). Subjects and methods: epidemiological, observational, analytical, cross-sectional. 200 newborns were analyzed. IL-6 was determined by Elisa. Results: newborn mean gestational age 38.4±2 weeks, mean weight 2871±532.4 grams, cutoff point interleukin 6 ≤14pg/uL; mean of IL6. 58±99,1 pg/uL; male sex was 43.9%, female sex 56.1%; preeclampsia of the mother 22.4%, prenatal infection of the urinary tract 20.4%; vaginitis/vaginosis 19.4%; IL6 values ≤ 14 pg/uL in 63.3% of patients; IL6 values of >14 pg/uL 36.7%; relationship with sepsis in all, p<0.05; relationship of prenatal pre-maternity of the mother and neonatal sepsis. p<0.05; relationship between vaginitis/vaginosis of the mother with neonatal sepsis; p<0.05; OR: 38.88 IC95% (4.912-307.728); association between sepsis and risk factors, IL6, gestational age in weeks, weight, prenatal preeclampsia, prenatal urinary tract infection, vaginitis/vaginosis, p<0.05. Conclusion: It is concluded that there is a relationship of risk factors, such as, gestational age in weeks, weight, prenatal preeclampsia, prenatal UTI, vaginitis/vaginosis and values of interleukin 6 ≤ 14 pg/uL. The mean gestational age was 38.4 weeks, and average weight 2871 grams in the newborns analyzed.
... The resolution of all these forms of abnormal microbiota will be a major challenge for future treatment studies. The new insights in the differential diagnosis of all types of abnormal vaginal microbiota have created renewed interest in screening and treating pregnant and non-pregnant women to prevent acquisition of STI or pregnancy complications as preterm labour [26]. ...
Purpose:
In the vagina of healthy reproductive-aged women, several microbial species maintain a finely tuned mutualistic relationship with the host providing the first-line of defense against the colonization by opportunistic pathogens, which are the leading cause of dysbiosis or vaginal infections (bacterial vaginosis, vulvovaginal candidiasis, and aerobic vaginitis). The use of probiotic lactobacilli to prevent vaginal infections has a good rationale, and an excellent safety record, but so far only a few strains have been clinically proven to be effective, particularly to prevent BV. The aim of the clinical trial was to evaluate the changes in Nugent score in women with intermediate vaginal microbiota treated with oral Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001 mixture, in combination with bovine lactoferrin RCX™ (Respecta®) or placebo, for 15 days.
Methods:
Vaginal swabs were collected from each woman at baseline and at the end of probiotic treatment and analyzed by RT-PCR. Both symptoms of abnormal vaginal micorbiota and adverse effects were assessed throughout the study.
Results:
The results showed that oral intake of lactobacilli/lactoferrin mixture led to significant vaginal colonization by L. acidophilus GLA-14 and L. rhamnosus HN001 showing that both strains can colonize vagina following oral ingestion. The effect of such colonization is correlated with the restoration of normal Nugent score (values 0-3) and an improvement of symptoms of abnormal vaginal micorbiota including itching and discharge.
Conclusions:
Oral consumption of lactobacilli/lactoferrin complex corroborates the effectiveness of using lactobacilli for supporting vaginal health and provides a rational basis for future studies on vaginal infections.
... In another study, probiotics were given to pregnant women with a history of bacterial vaginosis. Probiotic treatment lowered the rate of preterm delivery (Krauss-Silva et al. 2010). ...
... Several studies in animal models have suggested that probiotics increased absorption of Ca and Fe (Capcarova et al. 2010(Capcarova et al. , 2011. In another study, iron fortified and probiotics fermented milk increased serum Ca and Fe levels in preschool children (Krauss-Silva et al. 2010). Limited data is available regarding the effect of probiotics in pregnant women with reference to Ca and Fe. ...
... Вагінальний секрет в нормі містить 10 8 -10 12 КУО/мл мікроорганізмів, при цьому факультативно-анаеробні бактерії становлять 10 3 -10 5 КУО/ мл, анаеробні -10 5 -10 9 КУО/мл. Ряд авторів відмічають, що співвідношення анаеробів і аеробів становить 10 : 1 [14,15]. ...
... Органічні кислоти, які продукуються грамнегативними анаеробами, а також бактеріями роду Мobiluncus, зокрема янтарна кислота, інгибують функціональну активність полінуклеарних нейтрофільних гранулоцитів, із чим зв'язують малу кількість останніх або їх повна відсутність у виділеннях з піхви при бактеріальному вагінозі [5,15]. До асоціаціянтів мікробіоценозу піхви належать генітальні мікоплазми та гриби роду Candida, які можуть існувати при кислій рН піхви і не вступають в конкуренцію з лактобацилами. ...
Збільшення частоти запальних захворювань жіночих статевих органів обумовлено не тільки інфекціями, що передаються статевим шляхом, але і мікроорганізмами, які вважаються нормальними представниками екосистеми піхви. Порушення мікробіоценоза піхви призводить до хронізації запального процесу в органах малого таза, ускладненого перебігу вагітності, збільшєння ризику внутрішньоутробного інфікування плода. Тому надзвичайно важливе застосування пробіотиків, що мають високу антагоністичну активність проти патогенної і умовно-патогенної флори піхви. Висока терапевтична ефективність комплексного пробіотика біоселак дозволяє використовувати його як в комплексній, так і монотерапії для лікування і профілактики запальних захворювань жіночих статевих органів.
... The outcome gathered from various studies conducted in recent years have been remarkably consistent and have supported the hypothesis that antibiotic treatment before 20 weeks gestation reduces the risk of preterm birth. (1,2) It is concluded that screening for abnormal vaginal flora cannot be generalized but it may be safely carried out in pregnant women who have a previous history of preterm labour. Vol.6; Issue: 4; April 2016 ...
Preterm labour and low birth weight is a big concern in developing country like India. Abnormal vaginal flora in asymptomatic mothers has been found to be a causative factor in recent emerging evidences. The outcome gathered from various studies conducted in recent years have been remarkably consistent and have supported the hypothesis that antibiotic treatment before 20 weeks gestation reduces the risk of preterm birth. (1,2) Screening for abnormal vaginal flora can be safely carried out in pregnant women who have a previous history of preterm labour. This study was conducted in asymptomatic pregnant woman with such past history with intervention as intravaginal antibiotic and probiotic pessary and looked for maternal and fetal outcomes. The most common vaginal infection detected in this group was BV (23.4%). Candidiasis was present in 6.6% of pregnant women. A small number of pregnant women (0.4%) had both BV and Candidiasis. Treatment of asymptomatic women having abnormal vaginal flora in early pregnancy was associated with a statistically significant decrease in the rate of preterm delivery and low birth weight. Lactobacillus in addition causes further advantage in beneficial effect of intravaginal antibiotic pessary.
... С использованием метагеномного анализа установлено, что в вагинальном микробиоме встречается до 20 видов лактобацилл [34,46,75,111]. Наиболее часто выделяются представители 4 видов: Lactobacillus crispatus, L. gasseri, L. iners и L. jensenii [34,88,95,109,117]. Несколько реже обнаруживаются представители видов L. acidophilus, L. fermentum, L. plantarum, L. brevis, L. casei, L. vaginalis, L. delbrueckii, L. salivarius, L. reuteri и L. rhamnosus [33,35,36,55,65,76,82]. ...
In recent decades increased interest in natural microbiome - microbial communities colonizing the mucous membranes and skin of human. Microbiome is involved in metabolic and genetic regulatory mechanisms of human life, and also creates a powerful defense of microorganism from colonizing alien microorganisms. Mouth, upper respiratory tract, gastrointestinal and urogenital tract, skin are populated by different types of microorganisms.
It was found that the breach of the vaginal microbiome associated with the development of bacterial vaginosis, nonspecific (aerobic), vaginitis and mycotic vaginitis. Numerous studies have confirmed the effectiveness of probiotic therapy in the treatment of patients with various forms of urological and obstetrical and gynecological pathology, aimed at restoring the natural microbiome.
