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Evaluation of Lactocare® Synbiotic Administration on the Serum Electrolytes and Trace Elements Levels in Psoriasis Patients: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial Study.
Akbarzadeh, A, Taheri, M, Ebrahimi, B, Alirezaei, P, Doosti-Irani, A, Soleimani, M, Nouri, F
Biological trace element research. 2022;200(10):4230-4237
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Psoriasis is an immune-mediated chronic inflammatory skin disorder characterised by plaques and lesions on the skin. While the etiopathogenesis of psoriasis is not completely understood, various mechanisms have been implicated, including changes in the composition of intestinal microbes, oxidative stress and changes in the levels of certain trace elements. Previous research has shown that fluctuations in trace minerals such as zinc and copper may contribute to the progression and progression of psoriasis. It is known that synbiotics, which are combinations of probiotics and prebiotics, have immune-modulating properties, and they may also enhance the absorption of trace minerals from food when consumed. This double-blind, randomised, placebo-controlled trial was conducted to randomly assign sixty-four patients with mild-to-moderate psoriasis to consume Lactocare, a symbiotic containing seven strains of probiotic bacteria and prebiotic fructooligosaccharide twice daily or a placebo for 12 weeks. Serum trace mineral levels were measured after 12 weeks of treatment, including Fe, K, Ca, Mg, P, Zn, Na, and Cu. A significant improvement in serum levels of zinc and calcium was observed in the symbiotic group after 12 weeks of treatment. Additionally, the symbiotic treatment significantly increased the levels of trace minerals such as Fe, Ca, Mg, P, Zn, and Na within the group compared to the baseline. Fe and Cu levels in the treatment group were affected by sex, with male participants showing significant differences. To evaluate the other benefits of symbiotic preparations in patients with psoriasis, further large-scale studies are required. Healthcare professionals can utilise the research to understand the immune-modulating and anti-inflammatory properties of symbiotic formulations such as Lactocare, as well as to understand how the consumption of Lactocare improves the absorption of trace minerals.
Abstract
BACKGROUND Despite the exact etiopathogenesis of psoriasis remains unknown, the increasing or decreasing of some trace elements and oxidative stress status are considered to play a role. In this study, the effect of Lactocare® synbiotic on the serum levels of trace elements including Zn, Cu, Mg, Na, Fe, P, Ca, and K in the patients with mild to moderate psoriasis was investigated. METHODS Sixty-four patients with mild to moderate psoriasis were included. Patients were randomly divided into treatment (n═32) and control (n═32) groups. The treatment group received Lactocare® and the control group received a placebo (two times daily for 12 weeks). Eight patients from the intervention group and 18 patients from the control group discontinued the study because of the recent COVID-19 condition. For routine trace element analysis, the blood samples were collected from all patients at the baseline as well as week 12 post-treatment. The serum was then isolated and the serum levels of trace elements including Fe, K, Ca, Mg, P, Zn, Na, and Cu were measured using an automatic electrolyte analyzer. For confirmation of the effect of Lactocare® on the alteration of serum levels of trace elements, intra-group analysis was performed at two interval times: baseline and week 12 post-treatment. RESULTS The serum levels of K, P, and Ca in the placebo group were significantly higher than that of the treatment group at baseline. Serum levels of Zn and Ca were significantly higher in the treatment group compared to the placebo group at week 12 post-treatment. Moreover, a significantly lower serum level of K, P, and Ca in the treatment group at the baseline compared to the placebo group was compensated on week 12 post-treatment. Intra-group analysis in the treatment group showed that the serum levels of Fe, Ca, Mg, P, Zn, and Na was significantly increased at week 12 post-treatment compared to baseline levels. Whereas, intra-group analysis in the control group showed only Ca has a significant difference between baseline and week 12 post-treatment. CONCLUSION The serum levels of Fe, Zn, P, Mg, Ca, and Na are increased significantly 12 weeks after oral administration of Lactocare® in psoriatic patients. The serum level of Fe and Cu is affected by sex at pre- and post-treatment. This study supports the concept that Lactocare® exerts beneficial effects in the gastrointestinal tract to improve mineral absorption in psoriatic patients.
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The Roles of Probiotics in the Gut Microbiota Composition and Metabolic Outcomes in Asymptomatic Post-Gestational Diabetes Women: A Randomized Controlled Trial.
Hasain, Z, Raja Ali, RA, Ahmad, HF, Abdul Rauf, UF, Oon, SF, Mokhtar, NM
Nutrients. 2022;14(18)
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Gestational Diabetes Mellitus (GDM) happens to some pregnant women during the second and third trimester of their pregnancy, increasing the risk of developing Type 2 Diabetes Mellitus by 10-fold later in life. Aberrant changes to the gut microbial composition in pregnant gestational diabetic women are found to have a negative effect on the metabolism that may carry on to the postpartum period. On the other hand, probiotics may have a host metabolism modifying effect by reducing inflammation and gut dysbiosis in asymptomatic post-GDM women. This 12-week randomised, double-blinded, controlled, parallel-group clinical trial looked at the effect of probiotic supplementation on inflammatory and metabolic outcomes in asymptomatic post-GDM women. The one hundred and thirty-two participants were randomised to receive either a probiotic formulation containing Lactobacillus and Bifidobacterium stains or a placebo. Participants in the probiotic group showed a significant improvement in fasting blood glucose, HbA1c, total cholesterol, triglycerides and high-sensitivity C-reactive protein compared to the placebo group. In addition, the probiotic supplementation led to an increase in Bifidobacterium adolescentis. Healthcare professionals can use the results of this study to understand the beneficial effects of probiotic supplements in post-GDM women. However, further robust studies are required to evaluate the functions of probiotic supplements in post-GDM women from different backgrounds.
Abstract
Probiotics are widely used as an adjuvant therapy in various diseases. Nonetheless, it is uncertain how they affect the gut microbiota composition and metabolic and inflammatory outcomes in women who have recently experienced gestational diabetes mellitus (post-GDM). A randomized, double-blind, placebo-controlled clinical trial involving 132 asymptomatic post-GDM women was conducted to close this gap (Clinical Trial Registration: NCT05273073). The intervention (probiotics) group received a cocktail of six probiotic strains from Bifidobacterium and Lactobacillus for 12 weeks, while the placebo group received an identical sachet devoid of living microorganisms. Anthropometric measurements, biochemical analyses, and 16S rRNA gene sequencing results were evaluated pre- and post-intervention. After the 12-week intervention, the probiotics group's fasting blood glucose level significantly decreased (mean difference -0.20 mmol/L; p = 0.0021). The HbA1c, total cholesterol, triglycerides, and high-sensitivity C-reactive protein levels were significantly different between the two groups (p < 0.05). Sequencing data also demonstrated a large rise in the Bifidobacterium adolescentis following probiotic supplementation. Our findings suggest that multi-strain probiotics are beneficial for improved metabolic and inflammatory outcomes in post-GDM women by modulating gut dysbiosis. This study emphasizes the necessity for a comprehensive strategy for postpartum treatment that includes probiotics to protect post-GDM women from developing glucose intolerance.
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Vitamin D and probiotic co-supplementation affects mental health, hormonal, inflammatory and oxidative stress parameters in women with polycystic ovary syndrome.
Ostadmohammadi, V, Jamilian, M, Bahmani, F, Asemi, Z
Journal of ovarian research. 2019;12(1):5
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Polycystic ovary syndrome (PCOS) is a common cause of female infertility. Whilst the exact cause of PCOS is not known, high levels of male hormones, inflammation and oxidative damage are thought to contribute to the development of PCOS. Both probiotics and vitamin D supplements have been demonstrated to have anti-inflammatory and anti-oxidant effects. The aim of this study was to determine the effect of combined vitamin D and probiotic supplementation on mental health, hormonal, inflammatory and oxidative stress parameters in women with PCOS. This randomised, double-blinded, placebo-controlled clinical trial was carried out on 60 women with PCOS aged 18-40 years old in Iran. The women were randomly allocated to take either 50,000 IU vitamin D every 2 weeks plus 8 × 109 CFU/day probiotic or a placebo for 12 weeks. The probiotic capsule contained four strains: Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus reuteri and Lactobacillus fermentum (2 × 109 CFU/g each). Vitamin D and probiotic supplementation significantly improved mental health and general health scores, compared with the placebo. Vitamin D and probiotic supplementation was associated with a significant reduction in total testosterone (mean reduction of 0.19 ng/mL), excess body/facial hair, high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde (MDA) levels, and a significant increase in total antioxidant capacity (TAC) and total glutathione (GSH) levels, compared with the placebo. Vitamin D and probiotic supplementation did not affect serum sex-hormone binding globulin (SHBG) or nitric oxide levels. There were no effects on acne or alopecia. The authors concluded that the co-administration of vitamin D and probiotic for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, hirsutism, hs-CRP, plasma TAC, GSH and MDA levels
Abstract
OBJECTIVE The aim of this study was to determine the effect of vitamin D and probiotic co-administration on mental health, hormonal, inflammatory and oxidative stress parameters in women with polycystic ovary syndrome (PCOS). METHODS This randomized, double-blinded, placebo-controlled clinical trial was carried out on 60 subjects, aged 18-40 years old. Subjects were randomly allocated to take either 50,000 IU vitamin D every 2 weeks plus 8 × 109 CFU/day probiotic (n = 30) or placebo (n = 30) for 12 weeks. RESULTS Vitamin D and probiotic co-supplementation, compared with the placebo, significantly improved beck depression inventory [β (difference in the mean of outcomes measures between treatment groups) - 0.58; 95% CI, - 1.15, - 0.02; P = 0.04], general health questionnaire scores (β - 0.93; 95% CI, - 1.78, - 0.08; P = 0.03) and depression, anxiety and stress scale scores (β - 0.90; 95% CI, - 1.67, - 0.13; P = 0.02). Vitamin D and probiotic co-supplementation was associated with a significant reduction in total testosterone (β - 0.19 ng/mL; 95% CI, - 0.28, - 0.10; P < 0.001), hirsutism (β - 0.95; 95% CI, - 1.39, - 0.51; P < 0.001), high-sensitivity C-reactive protein (hs-CRP) (β - 0.67 mg/L; 95% CI, - 0.97, - 0.38; P < 0.001) and malondialdehyde (MDA) levels (β - 0.25 μmol/L; 95% CI, - 0.40, - 0.10; P = 0.001), and a significant increase in total antioxidant capacity (TAC) (β 82.81 mmol/L; 95% CI, 42.86, 122.75; P < 0.001) and total glutathione (GSH) levels (β 40.42 μmol/L; 95% CI, 4.69, 76.19; P = 0.02), compared with the placebo. CONCLUSIONS Overall, the co-administration of vitamin D and probiotic for 12 weeks to women with PCOS had beneficial effects on mental health parameters, serum total testosterone, hirsutism, hs-CRP, plasma TAC, GSH and MDA levels. TRIAL REGISTRATION This study was retrospectively registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( IRCT20170513033941N37 ).