Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria : a multicenter, randomized, double-blind, and placebo-controlled trial

Objective: The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. Patients and methods: The study was a multicenter, randomized, double-blind, and placebocontrolled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4-6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag®, or a placebo (one capsule for seven consecutive days vaginally). The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Results: Administration of inVag contributed to a significant decrease (between visits) in both vaginal pH (P<0.05) and Nugent score (P<0.05), and a significant increase in the abundance of Lactobacillus between visit I and visits III and IV (P<0.05). Molecular typing revealed the presence of Lactobacillus strains originating from inVag in 82% of women taking the drug at visit III, and 47.5% at visit IV. There was no serious adverse event related to inVag administration during the study. Conclusion: The probiotic inVag is safe for administration to sustainably restore the healthy vaginal microbiota, as demonstrated by predominance of the Lactobacillus bacteria in vaginal microbiota

Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis : a randomised, double-blind, placebo-controlled trial

BACKGROUND: This multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV). METHODS: Patients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5–6 (I, II, II bis – if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18–50-year-old women who were randomised. RESULTS: BV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p < 0.05) compared with placebo; AV relapse was delayed by up to 76 % (p < 0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment. CONCLUSION: This study demonstrated that oral probiotics lengthened remission in patients with recurrent BV/AV and improved clinical and microbiological parameters. TRIAL REGISTRATION: NCT01993524; 20 November 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12905-015-0246-6) contains supplementary material, which is available to authorized users

Metabolic control in type 2 diabetic patients treated by general practitioners and reffered to the specialists - preliminary results of the project &#8220;The Improvement of Glycaemic Control&#8221;

WSTĘP. Mimo że cele kontroli glikemii zostały jasno zdefiniowane, odsetek pacjentów wyrównanych metabolicznie sukcesywnie się zmniejsza. Przyczyną tego stanu może być narastająca liczba chorych, brak możliwości zapewnienia wszystkim chorym specjalistycznej opieki oraz trudności w realizacji założeń Polskiego Towarzystwa Diabetologicznego w zakresie tak zwanej opieki łączonej. Celem niniejszej pracy jest ocena wyrównania metabolicznego u chorych na cukrzycę typu 2 leczonych w poradniach lekarzy rodzinnych kierowanych do specjalisty w ramach programu &#8222;Poprawa Kontroli Glikemii&#8221;. MATERIAŁ I METODY. Analizę przeprowadzono na podstawie danych dotyczących 5812 chorych na cukrzycę typu 2 zakwalifikowanych do programu &#8222;Poprawa Kontroli Glikemii&#8221;, prowadzonych przez lekarzy rodzinnych, a spełniających kryteria włączenia, które obejmowały: terapię doustnymi lekami hipoglikemizującymi w maksymalnych dawkach i/lub insuliną; glikemię na czczo (FPG) > 150 mg/dl; glikemię 2 godziny po posiłku (PPG) > 200 mg/dl. U chorych obliczano wskaźnik masy ciała (BMI), mierzono ciśnienie tętnicze, oznaczono profil lipidowy oraz hemoglobinę glikowaną (gdy HbA1c wynosiła ponad 8%, chorych kierowano na konsultację diabetologiczną w celu modyfikacji leczenia oraz edukacji). WYNIKI. Średnia wartość HbA1c wynosiła 8,8%. U 18,5% chorych HbA1c była mniejsza od 7%. Średnie ciśnienie tętnicze wynosiło 140/83 mm Hg. Docelowe wartości w zakresie frakcji LDL stwierdzono u 32,9% chorych, w zakresie cholesterolu całkowitego - u 27,5%, w zakresie frakcji HDL - u 71,1%, a w zakresie stężenia triglicerydów - u 17,6%. Średnia wartość BMI wynosiła 32 &#177; 5,5 kg/m2. U 7,5% chorych stwierdzono prawidłową masę ciała, u 38,5% - nadwagę, a u pozostałych 54% - otyłość. WNIOSKI. Uzyskane wyniki obserwacji chorych na cukrzycę typu 2 kierowanych przez lekarzy rodzinnych do specjalisty wskazują na niedostateczną kontrolę metaboliczną. Dane sugerują potrzebę wprowadzenia zintegrowanej opieki łączonej, umożliwiającej kompleksową realizację założonych celów terapeutycznych.BACKGROUND. Although the glycaemic targets have been clearly defined, the percentage of the patients metabolically well controlled is progressively decreasing. The cause of this condition may be a growing number of the patients with diabetes, the lack of possibilities to provide all all of them with specialist care as well as difficulties to implement recommendations of the Polish Diabetes Association concerning the so called &#8220;shared care&#8221;. The aim of this study was the evaluation of metabolic control in type 2 diabetic patients treated in primary care settings and referred to specialist within the scope of the project &#8220;the Improvement of Glycaemic Control&#8221;. MATERIAL AND METHODS. The analysis was performed in 5812 type 2 diabetic patients included into &#8220;The Improvement of Glycaemic Control&#8221; programme and treated by general practitioners. The inclusion criteria were: treatment with oral hypoglycaemic agents in maximal doses and/or with insulin, fasting glycaemia > 150 mg/dl, 2-hour postprandial glycaemia > 200 mg/dl. Body mass index (BMI), HbA1c level, blood pressure and lipids were assessed. The patients were referred to specialists when HbA1c > 8% in order to modify antidiabetic treatment and educate. RESULTS. The mean HbA1c value was 8,8%. HbA1c < 7% was in 18,5% patients. Mean blood pressure was 140/83 mm Hg. 32,9% patients had target values of LDL, 27,5% patients of total cholesterol, 71,1% patients of HDL and 17,6% patients of triglycerides. BMI was 32 &#177; 5.5 kg/m2, 7,5% patients had normal BMI, 38,5% were overweight, and 54% were obese. CONCLUSIONS. The obtained results indicate insufficient metabolic control in type 2 diabetic patients referred by GP&#8217;s to specialists. The data point to the need of integrated, shared care which enables implementation of the assumed therapeutic aims in a full and complex way