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Serum cytokine patterns are modulated in infants fed formula with probiotics or milk fat globule membranes: A randomized controlled trial.
Li, X, Peng, Y, Li, Z, Christensen, B, Heckmann, AB, Lagerqvist, C, Stenlund, H, Lönnerdal, B, Hernell, O, West, CE
PloS one. 2021;(5):e0251293
Abstract
BACKGROUND Proteins and lipids of milk fat globule membrane (MFGM) and probiotics are immunomodulatory. We hypothesized that Lactobacillus paracasei ssp. paracasei strain F19 (F19) would augment vaccine antibody and T helper 1 type immune responses whereas MFGM would produce an immune response closer to that of breastfed (BF) infants. OBJECTIVE To compare the effects of supplementing formula with F19 or bovine MFGM on serum cytokine and vaccine responses of formula-fed (FF) and BF infants. DESIGN FF infants were randomized to formula with F19 (n = 195) or MFGM (n = 192), or standard formula (SF) (n = 194) from age 21±7 days until 4 months. A BF group served as reference (n = 208). We analyzed seven cytokines (n = 398) in serum at age 4 months using magnetic bead-based multiplex technology. Using ELISA, we analyzed anti-diphtheria IgG (n = 258) and anti-poliovirus IgG (n = 309) concentrations in serum before and after the second and third immunization, respectively. RESULTS Compared with SF, the F19 group had greater IL-2 and lower IFN-γ concentrations (p<0.05, average effect size 0.14 and 0.39). Compared with BF, the F19 group had greater IL-2, IL-4 and IL-17A concentrations (p<0.05, average effect size 0.42, 0.34 and 0.26, respectively). The MFGM group had lower IL-2 and IL-17A concentrations compared with SF (p<0.05, average effect size 0.34 and 0.31). Cytokine concentrations were comparable among the MFGM and BF groups. Vaccine responses were comparable among the formula groups. CONCLUSIONS Contrary to previous studies F19 increased IL-2 and lowered IFN-γ production, suggesting that the response to probiotics differs across populations. The cytokine profile of the MFGM group approached that of BF infants, and may be associated with the previous finding that infectious outcomes for the MFGM group in this cohort were closer to those of BF infants, as opposed to the SF group. These immunomodulatory effects support future clinical evaluation of infant formula with F19 or MFGM.
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Safety assessment of Streptococcus salivarius DB-B5 as a probiotic candidate for oral health.
Li, X, Fields, FR, Ho, M, Marshall-Hudson, A, Gross, R, Casser, ME, Naito, M
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association. 2021;:112277
Abstract
Streptococcus salivarius DB-B5 was previously isolated from the supragingival plaque of a healthy female adult and selected for development as a probiotic candidate for oral health. Probiotics are an important emerging therapeutic method for preventing, treating, and maintaining oral health. Although S. salivarius is a predominant member of the commensal oral microbiota and generally regarded as a safe species, it is recognized that each strain needs to be comprehensively assessed for safety. This study describes the in silico, in vitro, and clinical testing that were conducted to evaluate the safety of S. salivarius DB-B5. Both 16S rRNA and multi-gene phylogenetic reconstruction was used to confirm the taxonomic identity of this strain. Bioinformatic analysis of the genome demonstrated the absence of transmissible antibiotic resistance genes or virulence factors. Phenotypic testing further showed S. salivarius DB-B5 to be susceptible to clinically relevant antibiotics. S. salivarius DB-B5 displayed weak alpha-hemolysis, and does not produce biogenic amines. In a randomized, double-blind, placebo-controlled clinical study, consumption of S. salivarius DB-B5 at 10 billion CFU/day for 4 weeks by healthy adults was safe and well-tolerated (ClinicalTrials.gov registry number NCT04492631). This work has indicated that S. salivarius DB-B5 is a safe probiotic candidate.
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The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial.
Bai, T, Zeng, H, Long, Y, Li, X, Sun, X, Lan, Y, Gao, L, Zhang, L, Feng, Z, Hou, X
Trials. 2020;(1):597
Abstract
BACKGROUND Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients' quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy; however, in a lack of high-quality evidence of efficacy, no strain- and dose-specific probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the Bifidobacterium quadruple viable tablet in the treatment of IBS-D. METHODS/DESIGN A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients who fulfill the eligibility criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the Bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency; the secondary outcome includes evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL, and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events, and concomitant medication will be taken into account for intervention safety assessment during the trial. DISCUSSION This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the Bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotic intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis. TRIAL REGISTRATION ChiCTR1800017721 . Registered on 10 August 2018.
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Efficacy of prebiotics and probiotics for functional dyspepsia: A systematic review and meta-analysis.
Zhang, J, Wu, HM, Wang, X, Xie, J, Li, X, Ma, J, Wang, F, Tang, X
Medicine. 2020;(7):e19107
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Abstract
BACKGROUND Functional dyspepsia (FD) is a functional gastrointestinal disorder. Evidence suggests that disturbance of the gastrointestinal microbiota may be implicated in FD. We performed a systematic review and meta-analysis to examine the efficacy of prebiotics and probiotics for FD. METHODS MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched (through September 2018). Randomized controlled trials (RCTs) that recruited adults with FD and that compared prebiotics, probiotics, or synbiotics with placebo or no therapy were eligible. Eligibility assessment and data extraction were performed by two independent researchers. Dichotomous symptom data were pooled to obtain a relative risk (RR) with a 95% confidence interval (CI) of remaining symptomatic after therapy. Continuous data were pooled using a standardized or weighted mean difference with a 95% CI. RESULTS The search strategy identified 1062 citations. Five RCTs were eligible for inclusion. The RR of FD symptoms improving with probiotics or probiotics vs placebo was 1.15 (95% CI 1.01-1.30). Probiotics and prebiotics had beneficial effects on symptom scores of FD. Data for synbiotics in the context of FD were sparse, and no definite conclusions could be drawn. ETHICS AND DISSEMINATION This study belongs to the category of systematic reviews, not clinical trials. Therefore, it does not require ethical approval. The results of this study will be published in influential international academic journals related to this topic. CONCLUSION Probiotics and prebiotics seemed to be effective treatments for FD, although the individual species and strains that are the most beneficial remain unclear. Using only probiotics failed to improve the symptoms of FD. Further evidence is required before the role of probiotics, prebiotics, and synbiotics in FD can be fully understood.
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Probiotics for preventing postoperative infection in colorectal cancer patients: a systematic review and meta-analysis.
Ouyang, X, Li, Q, Shi, M, Niu, D, Song, W, Nian, Q, Li, X, Ding, Z, Ai, X, Wang, J
International journal of colorectal disease. 2019;(3):459-469
Abstract
PURPOSE Postoperative infection has seriously affected the prognosis of cancer patients, while probiotics have been increasingly used to prevent postoperative infection in clinical practice. This study aimed to evaluate the preventive effect of probiotics on infection after colorectal cancer (CRC) surgery. METHODS Related clinical trial reports were collected from Pubmed, Embase, Cochrane Library as well as China National Knowledge Infrastructure (CNKI) databases. These reports were then strictly screened, and information as well as data were extracted. Finally, the enrolled studies were evaluated by systematic review and meta-analysis using STATA v11 and Revman v5.2. RESULTS Probiotics administration contributed to the reduction of overall infection rate after colorectal surgery, with a pooled odds ratio (OR) of 0.51 (95% CI: 0.38-0.68, P = 0.00). Meanwhile, the incidence of incision infection (pooled OR = 0.59, 95% CI 0.39-0.88, P = 0.01) and pneumonia (pooled OR = 0.56, 95% CI 0.32-0.98, P = 0.04) as well as the first flatus time (SMDs = - 0.70, 95% CI - 1.13-- 0.27, P = 0.002) were also reduced by probiotics. In addition, urinary tract infection, anastomotic leakage, and duration of postoperative pyrexia were also analyzed, which displayed no statistical differences compared with those of control. CONCLUSION Probiotics have potential efficacy on preventing postoperative infection and related complications in cancer patients undergoing colorectal surgery.
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Effect of probiotics on metabolic profiles in type 2 diabetes mellitus: A meta-analysis of randomized, controlled trials.
Li, C, Li, X, Han, H, Cui, H, Peng, M, Wang, G, Wang, Z
Medicine. 2016;(26):e4088
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Abstract
Type 2 diabetes mellitus (T2DM) is a prevalent metabolic disease which is imposing heavy burden on global health and economy. Recent studies indicate gut microbiota play important role on the pathogenesis and metabolic disturbance of T2DM. As an effective mean of regulating gut microbiota, probiotics are live micro-organisms that are believed to provide a specific health benefit on the host. Whether probiotic supplementation could improve metabolic profiles by modifying gut microbiota in T2DM or not is still in controversy.The aim of the study is to assess the effect of probiotic supplementation on metabolic profiles in T2DM.We searched PubMed, EMBASE, and Cochrane Library up to 12 April 2016. Two review authors independently assessed study eligibility, extracted data, and evaluated risk of bias of included studies. Data were pooled by using the random-effect model and expressed as standardized mean difference (SMD) with 95% confidence interval (CI). Heterogeneity was assessed and quantified (I).A total of 12 randomized controlled trials (RCTs) were included. Lipid profiles (n = 508) and fasting blood glucose (FBG) (n = 520) were reported in 9 trials; the homeostasis model of assessment for insulin resistance index (HOMA-IR) (n = 368) and glycosylated hemoglobin (HbA1c) (n = 380) were reported in 6 trials. Probiotics could alleviate FBG (SMD -0.61 mmol/L, 95% CI [-0.92, -0.30], P = 0.0001). Probiotics could increase high-density lipoprotein-cholesterol (HDL-C) (SMD 0.42 mmol/L, 95% CI [0.08, 0.76], P = 0.01). There were no significant differences in low-density lipoprotein-cholesterol (LDL-C), total cholesterol (TC), triglyceride (TG), HbA1c and HOMA-IR between the treatment group and the control group.Probiotics may improve glycemic control and lipid metabolism in T2DM. Application of probiotic agents might become a new method for glucose management in T2DM.
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The efficacy and safety of probiotics intervention in preventing conversion of impaired glucose tolerance to diabetes: study protocol for a randomized, double-blinded, placebo controlled trial of the Probiotics Prevention Diabetes Programme (PPDP).
Yan, Q, Li, X, Feng, B
BMC endocrine disorders. 2015;:74
Abstract
BACKGROUND Alterations in intestinal microbiota correlate with risk of development of obesity and type 2 diabetes. Probiotics have been suggested to play an important role in the management of dysglycemia, although the evidence is limited. In this study, we aim to explore the efficacy and safety of probiotics intervention in preventing type 2 diabetes in Chinese patients with impaired glucose tolerance. METHODS/DESIGN A 24-month randomized intervention is conducted from January 2014 to December 2016. The target sample size for intervention is 200 middle-aged men and women aged 30-65 year-old with impaired glucose tolerance. Participants with persistent impaired glucose tolerance were assigned to group A (tablet A) and B (tablet B) in sequential order. The participants and investigators were blinded to the assignment. The primary outcome is development of diabetes. The secondary outcome measures include body composition, biochemical variables and the safety of the probiotics. DISCUSSION The results from this trial will provide the evidence on the efficacy and safety of probiotics administration in preventing conversion of impaired glucose tolerance to diabetes in a Chinese context. TRIAL REGISTRATION ChiCTRTRC13004024.
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Diet, but not oral probiotics, effectively reduces urinary oxalate excretion and calcium oxalate supersaturation.
Lieske, JC, Tremaine, WJ, De Simone, C, O'Connor, HM, Li, X, Bergstralh, EJ, Goldfarb, DS
Kidney international. 2010;(11):1178-85
Abstract
We examined the effect of a controlled diet and two probiotic preparations on urinary oxalate excretion, a risk factor for calcium oxalate kidney stone formation, in patients with mild hyperoxaluria. Patients were randomized to a placebo, a probiotic, or a synbiotic preparation. This tested whether these probiotic preparations can increase oxalate metabolism in the intestine and/or decrease oxalate absorption from the gut. Patients were maintained on a controlled diet to remove the confounding variable of differing oxalate intake from food. Urinary oxalate excretion and calcium oxalate supersaturation on the controlled diet were significantly lower compared with baseline on a free-choice diet. Neither study preparation reduced urinary oxalate excretion nor calcium oxalate supersaturation. Fecal lactobacilli colony counts increased on both preparations, whereas enterococcal and yeast colony counts were increased on the synbiotic. Total urine volume and the excretion of oxalate and calcium were all strong independent determinants of urinary calcium oxalate supersaturation. Hence, dietary oxalate restriction reduced urinary oxalate excretion, but the tested probiotics did not influence urinary oxalate levels in patients on a restricted oxalate diet. However, this study suggests that dietary oxalate restriction is useful for kidney stone prevention.