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Supplementation with Bifidobacterium breve BR03 and B632 strains improved insulin sensitivity in children and adolescents with obesity in a cross-over, randomized double-blind placebo-controlled trial.
Solito, A, Bozzi Cionci, N, Calgaro, M, Caputo, M, Vannini, L, Hasballa, I, Archero, F, Giglione, E, Ricotti, R, Walker, GE, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(7):4585-4594
Abstract
BACKGROUND & AIMS Variations in gut microbiota might impact metabolism leading to body weight excess. We assessed the impact of a probiotic supplementation in pediatric obesity on weight, metabolic alterations, selected gut microbial groups, and functionality. METHODS Cross-over, double-blind, randomized control trial (BIFI-OBESE trial; NCT03261466). 101 youths (6-18 years, Tanner stage ≥2) with obesity and insulin-resistance on diet were randomized to 2 × 109 CFU/AFU/day of Bifidobacterium breve BR03 (DSM 16604) and B. breve B632 (DSM 24706) (51) or placebo (50) for 8 weeks with a 4-weeks wash-out period. RESULTS All subjects (M/F 54/47) completed the first 8 weeks, and 82 (M/F 43/39) the last part without adverse events. Mixed-effects models revealed a carry-over effect on many variables in the entire study, narrowing the analysis to the first 8 weeks before the wash-out periods. All subjects improved metabolic parameters, and decreased weight and Escherichia coli counts. Probiotics improved insulin sensitivity at fasting (QUICKI, 0.013 CI95%0.0-0.03) and during OGTT (ISI, 0.654 CI95%-0.11-1.41). Cytokines, GLP1, and target microbial counts did not vary. Of 25 SCFAs, acetic acid and acetic acid pentyl-ester relative abundance remained stable in the probiotics, while increased in the placebo (p < 0.02). A signature of five butanoic esters identified three clusters, one of them had better glucose responses during probiotics. CONCLUSION An 8 weeks treatment with B. breve BR03 and B632 had beneficial effects on insulin sensitivity in youths with obesity. Microbiota functionality could influence metabolic answers to probiotics. Long-term studies to confirm and enrich our findings are justified. Tailored probiotic treatments could be an additional strategy for obesity. TRIAL REGISTRATION NCT03261466.
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Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS Trial.
Fleming, P, Wilks, M, Eaton, S, Panton, N, Hutchinson, R, Akyempon, A, Hardy, P, Millar, MR, Costeloe, K
Pediatric research. 2021;(7):1818-1824
Abstract
BACKGROUND Uncertainty remains about the role of probiotics to prevent necrotising enterocolitis (NEC) some of which arises from the variety of probiotic interventions used in different trials, many with no prior evidence of potential efficacy. Mechanistic studies of intestinal barrier function embedded in a large probiotic trial could provide evidence about which properties of probiotics might be important for NEC prevention thus facilitating identification of strains with therapeutic potential. METHODS Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation were assessed from the second postnatal week in babies enrolled to a randomised controlled trial of B. breve BBG-001 (the PiPS trial). Results were compared by allocation and by stool colonisation with the probiotic. RESULTS Ninety-four preterm babies were recruited across six nested studies. B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation. No measure of intestinal barrier function showed differences. The PiPS trial found no evidence of efficacy to reduce NEC. CONCLUSIONS That the negative results of the PiPS trial were associated with failure of this probiotic to modify intestinal barrier function supports the possibility that the tests described here have the potential to identify strains to progress to large clinical trials. IMPACT Uncertainty about the therapeutic role of probiotics to prevent necrotising enterocolitis is in part due to the wide range of bacterial strains with no previous evidence of efficacy used in clinical trials. We hypothesised that mechanistic studies embedded in a probiotic trial would provide evidence about which properties of probiotics might be important for NEC prevention. The finding that the probiotic strain tested, Bifidobacterium breve BBG-001, showed neither effects on intestinal barrier function nor clinical efficacy supports the possibility that these tests have the potential to identify strains to progress to large clinical trials.
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Effect of Lactobacillus rhamnosus Probiotic in Early Pregnancy on Plasma Conjugated Bile Acids in a Randomised Controlled Trial.
Chen, Y, Lu, J, Wickens, K, Stanley, T, Maude, R, Stone, P, Barthow, C, Crane, J, Mitchell, EA, Merien, F, et al
Nutrients. 2021;(1)
Abstract
We have previously shown that probiotic supplementation with Lactobacillus rhamnosus HN001 (HN001) led to a reduced incidence of gestational diabetes mellitus (GDM). Here we investigate whether HN001 supplementation resulted in alterations in fasting lipids, insulin resistance, or bile acids (BAs) during pregnancy. Fasting plasma samples collected at 24-30 weeks' gestation, from 348 women randomised at 14-16 weeks' gestation to consume daily probiotic HN001 (n = 172) or a placebo (n = 176) were analysed for lipids, insulin, glucose and BAs. Women supplemented with HN001 had lower fasting glucose compared with placebo (p = 0.040), and lower GDM. Significant differences were found in fasting insulin, HOMA-IR, low density lipoprotein-cholesterol (LDL-c), high density lipoprotein (HDL)-c, triglycerides, total cholesterol, and BAs by GDM status. Lower fasting conjugated BAs were seen in women receiving HN001. A significant decrease of glycocholic acid (GCA) was found in older (age ≥ 35) women who received HN001 (p = 0.005), while GDM women showed significant reduced taurodeoxycholic acid (TDCA) (p = 0.018). Fasting conjugated BA was positively correlated with fasting glucose (r = 0.136, p = 0.020) and fasting insulin (r = 0.113, p = 0.036). Probiotic HN001 supplementation decreases conjugated BAs and might play a role in the improvement of glucose metabolism in women with pregnancy.
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Probiotic supplementation elicits favourable changes in muscle soreness and sleep quality in rugby players.
Harnett, JE, Pyne, DB, McKune, AJ, Penm, J, Pumpa, KL
Journal of science and medicine in sport. 2021;(2):195-199
Abstract
UNLABELLED Probiotic supplementation may offer team sport athletes a range of benefits beyond the immune and gastrointestinal systems. OBJECTIVES To examine the effects of a probiotic formulation on perceptual markers of sleep quality and quantity, and muscle soreness, leg heaviness and motivation in elite rugby union athletes. METHODS A double-blind randomised controlled trial involving 19 elite male rugby athletes was conducted over 17 weeks encompassing both domestic and international competition. Psychometric variables and salivary biomarkers were assessed twice a week. Athletes were assigned either a daily probiotic (Ultrabiotic 60™) and Saccharomyces boulardii (during international competition) or a placebo. Associations between psychometric scores for perceptual and salivary biomarkers of sleep (melatonin) and inflammation C-reactive protein (CRP) were investigated. RESULTS Muscle soreness was ∼0.5 units lower (F(1, 343)=42.646, p<0.0001) and leg heaviness scores ∼0.7 units lower (F(1, 334)=28.990, p<0.0001) in the probiotic group compared to the placebo group. Across both groups, as self-reported muscle soreness scores and salivary CRP concentrations increased, sleep quantity, quality and motivation scores decreased. Conversely as muscle soreness scores and CRP decreased, sleep quantity and quality, and motivation scores improved. CONCLUSIONS A long-term programme of probiotic supplementation in international-level rugby union players may yield favourable effects on self-reported muscle soreness and sleep quality associated with muscle soreness during training and competitions.
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The effect of probiotic supplementation on the risk of gestational diabetes mellitus among high-risk pregnant women: A parallel double-blind, randomized, placebo-controlled clinical trial.
Shahriari, A, Karimi, E, Shahriari, M, Aslani, N, Khooshideh, M, Arab, A
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021;:111915
Abstract
BACKGROUND Based on a comprehensive search, we realized that the findings of the available literature are contradictory, and also limited data are available on Middle Eastern populations in terms of probiotic supplementation during the pregnancy. Therefore, the current double-blind, randomized, placebo-controlled clinical trial was carried out to investigate the effects of probiotic supplementation during pregnancy on the risk of gestational diabetes mellitus and also other maternal and neonatal outcomes. MATERIALS AND METHODS The pregnant women were randomized to either received probiotic supplement (n = 271) or placebo (n = 271) from the first half of the second trimester (14 weeks of pregnancy) up to 24 weeks when pregnant women routinely evaluated regarding the GDM. During the 24-28 weeks of pregnancy, mothers were evaluated regarding the presence of GDM using a 75 g oral glucose tolerance test (OGTT). The fasting blood glucose (FBG) was also evaluated within OGTT processes. Each 500 mg probiotic capsule was a mixture of Lactobacillus acidophilus LA1 (>7.5 × 109 CFU), Bifidobacterium longum sp54 cs (>1.5 × 109 CFU), and Bifidobacterium bifidum sp9 cs (>6 × 109 CFU). RESULTS Overall, 507 pregnant women make up our study population with a mean age of 32.03 years and a Body Mass Index (BMI) of 30.20 kg/m2. There was no significant difference between the intervention and the control group regarding FBG (88.68 vs. 89.61 mg/dL; P = 0.338), OGTT-1h (163.86 vs. 166.88; mg/dL; P = 0.116), and OGTT-2h (138.39 vs. 139.27; mg/dL; P = 0.599). The incidence of GDM in the intervention group was 41.9% which was not significantly different from the control group (40.2%) (P = 0.780). Likewise, no significant difference was detected in terms of other studied parameters. CONCLUSIONS It seems that probiotics supplementation of pregnant women from the first half of the second trimester up to 24 weeks of pregnancy does not reduce the risk of GDM, or improve other neonatal and maternal outcomes.
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Effect of synbiotics and probiotics supplementation on autoimmune diseases: A systematic review and meta-analysis of clinical trials.
Askari, G, Ghavami, A, Shahdadian, F, Moravejolahkami, AR
Clinical nutrition (Edinburgh, Scotland). 2021;(5):3221-3234
Abstract
BACKGROUND & AIMS Today synbiotics are considered as immunomodulatory agents. The current systematic review and meta-analysis investigated the effect of synbiotics and probiotics on inflammatory and oxidative stress markers in autoimmune disease. MATERIALS & METHODS The English literature search was performed using PubMed, Scopus, Web of Science, and the Central Cochrane Library through March 2020. Random effects models and generic inverse variance methods were used to synthesize quantitative data by STATA14. RESULTS From a total of 623 entries identified via searches, ten RCTs (n = 440; 216 as intervention, 224 as controls) were included. An additional eleven studies with same intervention and different markers were also explained systematically. The pooled effect size showed that Interleukin (IL)-6 (WMD = -7.79 pg/ml; 95% CI = -13.81, -1.77, P = 0.011), Tumor Necrosis Factor (TNF)-α (WMD = -1.05 pg/ml; 95% CI = -2.01, -0.10, P = 0.030), high sensitivity C-Reactive Protein (hs-CRP) (SMD = -0.58; 95% CI = -0.79, -0.37, P < 0.001), Malondialdehyde (MDA) (SMD = -0.36; 95% CI = -0.68, -0.04; P = 0.026), Homeostasis Model of Assessment-estimated Insulin Resistance (HOMA-IR) (WMD = -0.71; 95% CI = -1.05, -0.37, P < 0.001), and beta cell function (HOMA-β) (WMD = -15.18; 95% CI = -22.08, -8.28, P < 0.001) changed following probiotics (or synbiotics) supplementation. Also supplementation with doses more than 2 billion CFU could reduce IL-10 concentrations (WMD = -1.84; 95% CI = -2.23, 1.87; P < 0.001). Glutathione (GSH) and Total Antioxidant Capacity (TAC) levels did not influence by synbiotics and probiotics; insignificancy was remained after subgrouping for participants' age, study duration, and disease duration. CONCLUSION Our findings revealed that synbiotics and probiotics supplementation has significant effect on some inflammatory and oxidative stress markers; although, the number of trials was too small to powerful conclusion and further investigations may be needed.
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Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial.
Maldonado-Lobón, JA, Blanco-Rojo, R, Maldonado, J, Ali, MA, Almazán, MV, Suanes-Cabello, A, Callejón, E, Jaldo, R, Benavídes, MR, Negrillo, AM, et al
Beneficial microbes. 2021;(1):55-67
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Abstract
Infantile colic is a prevalent condition characterised by excessive crying with no effective treatment available. We aimed to evaluate the efficacy of Bifidobacterium breve CECT7263 and a combination of this and Lactobacillus fermentum CECT5716 versus simethicone in reducing the daily time spent crying in colicky infants. A multicentre randomised, open-label, parallel, controlled trial of 28 days was performed in 150 infants who were diagnosed with colic according to the Rome III criteria and who randomly received simethicone (80 mg/day; Simethicone group), B. breve CECT7263 (2×108 cfu/day, Bb group), or a combination of L. fermentum CECT5716 and B. breve CECT7263 (1×108 cfu/day per strain, Bb+Lf group). The main outcomes were minutes of crying per day and the percentage of reduction in daily crying from baseline. Data were analysed per intention to treat. All treatments significantly decreased the daily crying time at the end of the intervention (P-time <0.001). However, the infants in the Bb group had significantly decreased crying time from the first week of the study (P<0.05), whereas the Bb+Lf group and the simethicone group had significantly decreased crying time from the second week (P<0.05). The percentage of reduction in the minutes of crying from baseline in the Bb group was significantly higher than that in the Simethicone group every week of the intervention (-40.3 vs -27.6% at 1-week; -59.2 vs -43.2% at 2-weeks; -64.5 vs -53.5% at 3-week and -68.5 vs -59.5% at 4-weeks, P<0.05). Additionally, in the Bb group, infants had better night sleep, and parents reported a more positive mood at the end of the intervention. All the products used in the study were safe and well tolerated. In conclusion, the breastmilk-isolated probiotic strain B. breve CECT7263 is a safe and effective treatment for infantile colic, presenting an earlier and more robust effect than the reference prescribed drug, simethicone.
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Tweak to Treat: Reprograming Bacteria for Cancer Treatment.
Sieow, BF, Wun, KS, Yong, WP, Hwang, IY, Chang, MW
Trends in cancer. 2021;(5):447-464
Abstract
Recent advancements in cancer biology, microbiology, and bioengineering have spurred the development of engineered live biotherapeutics for targeted cancer therapy. In particular, natural tumor-targeting and probiotic bacteria have been engineered for controlled and sustained delivery of anticancer agents into the tumor microenvironment (TME). Here, we review the latest advancements in the development of engineered bacteria for cancer therapy and additional engineering strategies to potentiate the delivery of therapeutic payloads. We also explore the use of combination therapies comprising both engineered bacteria and conventional anticancer therapies for addressing intratumor heterogeneity. Finally, we discuss prospects for the development and clinical translation of engineered bacteria for cancer prevention and treatment.
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Potential beneficial role of probiotics on the outcome of COVID-19 patients: An evolving perspective.
Santacroce, L, Inchingolo, F, Topi, S, Del Prete, R, Di Cosola, M, Charitos, IA, Montagnani, M
Diabetes & metabolic syndrome. 2021;(1):295-301
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Abstract
BACKGROUND AND AIMS Probiotics can support the body's systems in fighting viral infections. This review is aimed to focus current knowledge about the use of probiotics as adjuvant therapy for COVID-19 patients. METHODS We performed an extensive research using the PubMed-LitCovid, Cochrane Library, Embase databases, and conducting manual searches on Google Scholar, Elsevier Connect, Web of Science about this issue. RESULTS We have found several papers reporting data about the potential role of probiotics as well as contrasting experimental data about it. CONCLUSIONS Most data show good results demonstrating that probiotics can play a significant role in fighting SARS-CoV-2 infection, also compared with their use in the past for various diseases. They seem effective in lowering inflammatory status, moreover in patients with chronic comorbidities such as cancer and diabetes, improving clinical outcomes.
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Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double-Blinded, Placebo-Controlled Pilot Trial.
Kong, XJ, Liu, J, Liu, K, Koh, M, Sherman, H, Liu, S, Tian, R, Sukijthamapan, P, Wang, J, Fong, M, et al
Nutrients. 2021;(5)
Abstract
Autism spectrum disorder (ASD) is a rapidly growing neurodevelopmental disorder. Both probiotics and oxytocin were reported to have therapeutic potential; however, the combination therapy has not yet been studied. We conducted a randomized, double-blinded, placebo-controlled, 2-stage pilot trial in 35 individuals with ASD aged 3-20 years (median = 10.30 years). Subjects were randomly assigned to receive daily Lactobacillus plantarum PS128 probiotic (6 × 1010 CFUs) or a placebo for 28 weeks; starting on week 16, both groups received oxytocin. The primary outcomes measure socio-behavioral severity using the Social Responsiveness Scale (SRS) and Aberrant Behavior Checklist (ABC). The secondary outcomes include measures of the Clinical Global Impression (CGI) scale, fecal microbiome, blood serum inflammatory markers, and oxytocin. All outcomes were compared between the two groups at baseline, 16 weeks, and 28 weeks into treatment. We observed improvements in ABC and SRS scores and significant improvements in CGI-improvement between those receiving probiotics and oxytocin combination therapy compared to those receiving placebo (p < 0.05). A significant number of favorable gut microbiome network hubs were also identified after combination therapy (p < 0.05). The favorable social cognition response of the combination regimen is highly correlated with the abundance of the Eubacterium hallii group. Our findings suggest synergic effects between probiotics PS128 and oxytocin in ASD patients, although further investigation is warranted.