1.
Effects of Loigolactobacillus coryniformis K8 CECT 5711 on the Immune Response of Elderly Subjects to COVID-19 Vaccination: A Randomized Controlled Trial.
Fernández-Ferreiro, A, Formigo-Couceiro, FJ, Veiga-Gutierrez, R, Maldonado-Lobón, JA, Hermida-Cao, AM, Rodriguez, C, Bañuelos, O, Olivares, M, Blanco-Rojo, R
Nutrients. 2022;(1)
Abstract
Elderly people are particularly vulnerable to COVID-19, with a high risk of developing severe disease and a reduced immune response to the COVID-19 vaccine. A randomized, placebo-controlled, double-blind trial to assess the effect of the consumption of the probiotic Loigolactobacillus coryniformis K8 CECT 5711 on the immune response generated by the COVID-19 vaccine in an elderly population was performed. Two hundred nursing home residents >60 yrs that had not COVID-19 were randomized to receive L. coryniformis K8 or a placebo daily for 3 months. All volunteers received a complete vaccination schedule of a mRNA vaccine, starting the intervention ten days after the first dose. Specific IgG and IgA antibody levels were analyzed 56 days after the end of the immunization process. No differences between the groups were observed in the antibody levels. During the intervention, 19 subjects had COVID-19 (11 receiving K8 vs. 8 receiving placebo, p = 0.457). Subgroup analysis in these patients showed that levels of IgG were significantly higher in those receiving K8 compared to placebo (p = 0.038). Among subjects >85 yrs that did not get COVID-19, administration of K8 tended to increase the IgA levels (p = 0.082). The administration of K8 may enhance the specific immune response against COVID-19 and may improve the COVID-19 vaccine-specific responses in elderly populations.
2.
Evidence-based mixture containing Lactobacillus strains and lactoferrin to prevent recurrent bacterial vaginosis: a double blind, placebo controlled, randomised clinical trial.
Russo, R, Karadja, E, De Seta, F
Beneficial microbes. 2019;(1):19-26
Abstract
Bacterial vaginosis (BV) is the most common cause of vaginal discomfort in women. It is characterised by abnormal vaginal microbiota with a depletion of lactobacilli and predominance of anaerobic microorganisms, mainly Gardnerella vaginalis and Atopobium vaginae. Although antibiotics represent an effective therapeutic option in the short-term, recurrent infections still remain a serious problem. Nowadays, evidence exists about the efficacy of probiotics for the management of BV. The aim of the current double blind, randomised clinical trial was to assess the efficacy of a probiotic mixture, including Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001, in combination with bovine lactoferrin, as adjuvant therapy to metronidazole in women with recurrent BV. In particular, normalisation of Nugent score, remission of symptoms and recurrences during a six-months follow-up were assessed. 48 adult women received metronidazole (500 mg twice daily) for 7 days and randomly assigned to take simultaneously either probiotics plus lactoferrin or placebo (2 capsules/day for 5 days followed by 1 capsule/day for 10 consecutive days; induction phase). The verum or placebo administration (1 capsule/day for 10 consecutive days) was repeated each month (maintenance phase) during the six months of follow-up starting the first day of menstrual cycle since the menstrual blood increases the vaginal pH and contributes to increase the risk of recurrences. The results showed that symptoms (vaginal discharge and itching), Nugent score and recurrence rate were significantly improved by probiotics mixture in association with lactoferrin. This alternative approach may represent a safe and effective remedy for the restoration of healthy vaginal microbiota in preventing recurrent BV.
3.
A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE).
Allen, SJ, Wareham, K, Wang, D, Bradley, C, Sewell, B, Hutchings, H, Harris, W, Dhar, A, Brown, H, Foden, A, et al
Health technology assessment (Winchester, England). 2013;(57):1-140
Abstract
BACKGROUND Antibiotic-associated diarrhoea (AAD) occurs most commonly in older people admitted to hospital and within 12 weeks of exposure to broad-spectrum antibiotics. Although usually a mild and self-limiting illness, the 15-39% of cases caused by Clostridium difficile infection [C. difficile diarrhoea (CDD)] may result in severe diarrhoea and death. Previous research has shown that probiotics, live microbial organisms that, when administered in adequate numbers, are beneficial to health, may be effective in preventing AAD and CDD. OBJECTIVES To determine the clinical effectiveness and cost-effectiveness of a high-dose, multistrain probiotic in the prevention of AAD and CDD in older people admitted to hospital. DESIGN A multicentre, randomised, double-blind, placebo-controlled, parallel-arm trial. SETTING Medical, surgical and elderly care inpatient wards in five NHS hospitals in the UK. PARTICIPANTS Eligible patients were aged ≥ 65 years, were exposed to one or more oral or parenteral antibiotics and were without pre-existing diarrhoeal disorders, recent CDD or at risk of probiotic adverse effects. Out of 17,420 patients screened, 2981 (17.1%) were recruited. Participants were allocated sequentially according to a computer-generated random allocation sequence; 1493 (50.1%) were allocated to the probiotic and 1488 (49.9%) to the placebo arm. INTERVENTIONS Vegetarian capsules containing two strains of lactobacilli and two strains of bifidobacteria (a total of 6 × 10(10) organisms per day) were taken daily for 21 days. The placebo was inert maltodextrin powder in identical capsules. MAIN OUTCOME MEASURES The occurrence of AAD within 8 weeks and CDD within 12 weeks of recruitment was determined by participant follow-up and checking hospital laboratory records by research nurses who were blind to arm allocation. RESULTS Analysis based on the treatment allocated included 2941 (98.7%) participants. Potential risk factors for AAD at baseline were similar in the two study arms. Frequency of AAD (including CDD) was similar in the probiotic (159/1470, 10.8%) and placebo arms [153/1471, 10.4%; relative risk (RR) 1.04; 95% confidence interval (CI) 0.84 to 1.28; p = 0.71]. CDD was an uncommon cause of AAD and occurred in 12/1470 (0.8%) participants in the probiotic and 17/1471 (1.2%) in the placebo arm (RR 0.71; 95% CI 0.34 to 1.47; p = 0.35). Duration and severity of diarrhoea, common gastrointestinal symptoms, serious adverse events and quality of life measures were also similar in the two arms. Total health-care costs per patient did not differ significantly between the probiotic (£8020; 95% CI £7620 to £8420) and placebo (£8010; 95% CI £7600 to £8420) arms. CONCLUSION We found no evidence that probiotic administration was effective in preventing AAD. Although there was a trend towards reduced CDD in the probiotic arm, on balance, the administration of this probiotic seems unlikely to benefit older patients exposed to antibiotics. A better understanding of the pathogenesis of AAD and CDD and the strain-specific effects of probiotics is needed before further clinical trials of specific microbial preparations are undertaken. Evaluation of the effectiveness of other probiotics will be difficult where other measures, such as antibiotic stewardship, have reduced CDD rates. TRIAL REGISTRATION This trial is registered as ISRCTN70017204. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 57. See the NIHR Journals Library website for further project information.
4.
Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with acute diarrhea: a multicenter, randomized study in primary care.
Grossi, E, Buresta, R, Abbiati, R, Cerutti, R, ,
Journal of clinical gastroenterology. 2010;:S35-41
Abstract
OBJECTIVES Few randomized studies have been carried out on adult patients affected by acute diarrhea especially in primary care, which is the natural context for this kind of disorder. Lactobacillus paracasei B 21060 is a novel strain of lactobacillus, which has been shown to be effective in relieving symptoms associated with diarrhea of irritable bowel syndrome subtype and in shortening diarrhea duration. In this study, we compared the therapeutic efficacy, safety, and tolerability of a new symbiotic formulation, Flortec, containing L. paracasei B-21060, with lactobacillus GG (FlorVis GG) in the treatment of acute presumed infectious diarrhea. METHODS Fourteen general practitioners working in the Perugia health authority district carried out a randomized controlled, parallel-group, open trial in 174 adult patients suffering from acute diarrhea (87 enrolled in the Flortec group and 87 in the FlorVis group). Both the products were administered according to their standard recommended dosage. The main efficacy criterion was the duration of diarrhea after beginning treatment. Treatment duration was 10 days. Enrolled patients kept a careful track of their symptoms noting them in a personal diary for 12 days. RESULTS The 2 groups resulted to be homogeneous at baseline with regard to prognostic variables. The mean duration of diarrhea from the start of treatment in the Flortec group was 4.24 (2.73 SD) days versus 5.09 (3.72 SD) days in the FlorVis group (P=0.09).Clinical success rates in terms of absence of abdominal pain and absence of diarrhea (defined as <2 bowel movements of watery or loose stool consistency) recorded at different time-points were statistically superior in the Flortec group (Kaplan-Meyer P=0.05 for both the symptoms). The physician judged that overall efficacy was good or very good in 91.8% of the patients in the Flortec group. The corresponding value in the FlorVis group was 83.7% (P=0.003). The 2 treatments showed a very good tolerability profile, with negligible and similar adverse event rates and similar concomitant medication usage rates. CONCLUSIONS Oral therapy with Flortec proved to be more effective than FlorVis GG in the treatment of acute diarrhea in adults treated at a primary care setting.
5.
Lactobacilli in the female genital tract in relation to other genital microbes and vaginal pH.
Rönnqvist, PD, Forsgren-Brusk, UB, Grahn-Håkansson, EE
Acta obstetricia et gynecologica Scandinavica. 2006;(6):726-35
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Abstract
BACKGROUND The relationship between lactobacilli and other microbes and the association with vaginal pH in the female genital tract were examined. The study also included evaluation of the possibility of supplying probiotics to the genital tract by using panty liners impregnated with the probiotic strain Lactobacillus plantarum LB931. METHODS This was a randomized, placebo-controlled, double-blind, multicenter study involving 191 healthy fertile women. Specified microbes were counted and vaginal pH was measured once a month for five consecutive months. RESULTS Major individual variations in the genital microflora composition and the vaginal pH were found among the women. The number of lactobacilli was significantly related to vaginal pH (p<0.001) and approximately 70% of the women were permanent carriers of individual lactobacilli strains. Women with high numbers of lactobacilli were less prevalent with Group B streptococci than women with low numbers (p=0.036), and these women had a lower mean vaginal pH. The number of lactobacilli also correlated with the prevalence of yeast. LB931 could be found in 86% of the labial samples and 54% of the vaginal samples. CONCLUSIONS High numbers of lactobacilli may contribute to a low vaginal pH and seem to have a negative influence on Group B streptococci. LB931 could be transferred from the panty liners to both the vagina and the labial fold.