Data on global analysis of clinical trials with probiotics.
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ABSTRACT:
SUBMITTER: Dronkers TMG
PROVIDER: S-EPMC7490816 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundEfforts to define research Common Data Elements try to harmonize data collection across clinical studies.ObjectiveOur goal was to analyze the quality and usability of data dictionaries of HIV studies.MethodsFor the clinical domain of HIV, we searched data sharing platforms and acquired a set of 18 HIV related studies from which we analyzed 26 328 data elements. We identified existing standards for creating a data dictionary and reviewed their use. To facilitate aggregation across studies, we defined three types of data dictionary (data element, forms, and permissible values) and created a simple information model for each type.ResultsAn average study had 427 data elements (ranging from 46 elements to 9 945 elements). In terms of data type, 48.6% of data elements were string, 47.8% were numeric, 3.0% were date and 0.6% were date-time. No study in our sample explicitly declared a data element as a categorical variable and rather considered them either strings or numeric. Only for 61% of studies were we able to obtain permissible values. The majority of studies used CSV files to share a data dictionary while 22% of the studies used a non-computable, PDF format. All studies grouped their data elements. The average number of groups or forms per study was 24 (ranging between 2 and 124 groups/forms). An accurate and well formatted data dictionary facilitates error-free secondary analysis and can help with data de-identification.ConclusionWe saw features of data dictionaries that made them difficult to use and understand. This included multiple data dictionary files or non-machine-readable documents, data elements included in data but not in the dictionary or missing data types or descriptions. Building on experience with aggregating data elements across a large set of studies, we created a set of recommendations (called CONSIDER statement) that can guide optimal data sharing of future studies.
| S-EPMC7535029 | biostudies-literature
Project description:With growing interest in the gut microbiome, prebiotics and probiotics have received considerable attention as potential treatments for depression and anxiety. We conducted a random-effects meta-analysis of 34 controlled clinical trials evaluating the effects of prebiotics and probiotics on depression and anxiety. Prebiotics did not differ from placebo for depression (d?=?-.08, p?=?.51) or anxiety (d?=?.12, p?=?.11). Probiotics yielded small but significant effects for depression (d?=?-.24, p?<?.01) and anxiety (d?=?-.10, p?=?.03). Sample type was a moderator for probiotics and depression, with a larger effect observed for clinical/medical samples (d?=?-.45, p?<?.001) than community ones. This effect increased to medium-to-large in a preliminary analysis restricted to psychiatric samples (d?=?-.73, p?<?.001). There is general support for antidepressant and anxiolytic effects of probiotics, but the pooled effects were reduced by the paucity of trials with clinical samples. Additional randomized clinical trials with psychiatric samples are necessary fully to evaluate their therapeutic potential.
| S-EPMC6584030 | biostudies-literature
Project description:BackgroundGinseng has a long history of widespread use and remarkable effects as traditional medicine, adjuvant and dietary supplement. The therapeutic value, diverse functionalities and rapid development of ginseng have driven a significant increase in the number of ginseng clinical trials, ranging from its use in various ailments, formulation to safety concerns. Despite the persistent interest in ginseng clinical research, the medical effectiveness of ginseng is inconclusive and there is a lack of bibliometric analysis of the hundreds of ginseng clinical trials.Aim of reviewThis review aims to provide an extensive overview of ginseng clinical trials over the past 40 years (1979-2018) in combination with a qualitative and quantitative analysis. The annual clinical trial analysis of time distribution, country and institution network analysis for space cooperation, statistical analysis for various functions, as well as efficiency and effect size were performed for global ginseng clinical trials. Besides, preparation categories, administration routes, and the safety of ginseng clinical trials were also investigated.Key scientific concepts of reviewThe 40-year journey of ginseng clinical trials has experienced emerging, boom, and stable or transitional stages. The global network of ginseng clinical trials has relevant regional distribution in Asia, North America and Europe. South Korea makes a great contribution to building up large research clusters and strong cooperation links. Universities are the key contributors to ginseng clinical trials. The development of ginseng products could be focused on the clinical trial in diseases with higher effectiveness or effect size, such as sexual function and cognitive & behavior and require rigorous investigations and evidence to evaluate safety. More attention should be paid to different effects from different preparations. We believe this review will provide new insights into the understanding of global ginseng clinical trials and identifies potential future perspectives for research and development of ginseng.
| S-EPMC8655123 | biostudies-literature
Project description:The aim of this systematic review is to evaluate whether the use of probiotics has any effect on the components of metabolic syndrome (MetS) before patients develop type 2 diabetes. A qualitative systematic review, following the Cochrane methodology, and a comprehensive literature search of randomized controlled trials (RCTs) were conducted in PubMed and Scopus from inception until 4 July 2019. According to our inclusion criteria, nine clinical studies were finally analyzed, corresponding to six RCTs. Probiotics intake in patients with MetS resulted in improvements in body mass index, blood pressure, glucose metabolism, and lipid profile in some studies. Regarding inflammatory biomarkers, probiotics also positively affected the soluble vascular cell adhesion molecule 1 (sVCAM-1), interleukine-6 (IL-6), tumor necrosis factor α (TNF-α), vascular endothelial growth factor (VEGF), and thrombomodulin. Despite the diversity of the published studies, the intake of probiotics for patients with MetS may offer a discrete improvement in some of the clinical characteristics of the MetS and a decrease in inflammatory biomarkers. Nevertheless, these beneficial effects seem to be marginal compared to drug therapy and a healthy lifestyle and clinically non-relevant.
| S-EPMC7019472 | biostudies-literature
Project description:Interventions: Ten subjects receive probiotic product contained 10 million CFU in viable form 3 times a day for 6 months,Ten subjects receive probiotic product contained 10 million CFU in non viable form 3 times a day for 6 months, Ten subjects receive product without probiotic 3 times a day for 6 months;Active Comparator Dietary Supplement,Active Comparator Dietary Supplement,Placebo Comparator Dietary Supplement;probiotic products in viable form,probiotic products in non viable form,Control
Primary outcome(s): reduceing of number of pathogens in gut at 6 months after intervention number of pathogens / Anova
Study Design: Randomized
| 2727906 | ecrin-mdr-crc
Project description:The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach.We used data from three randomized phase III trials monitored with a combination of complete SDV or partial SDV. After database lock, individual subject data were extracted from the clinical database and subjected to post hoc complete SDV. Error rates were calculated with focus on the degree of on study monitoring and relevance and analyzed for potential impact on end points.Data from a total of 2566 subjects including more than 3 million data fields were 100% source data verified post hoc. An overall error rate of 0.45% was found. No sites had 0% errors. 100% SDV yielded an error rate of 0.27% as compared with partial SDV having an error rate of 0.53% (P < 0.0001). Comparing partly and fully monitored subjects, minor differences were identified between variables of major importance to efficacy or safety.The findings challenge the notion that a 0% error rate is obtainable with on site monitoring. Data indicate consistently low error rates across the three trials analyzed. The use of complete vs. partial SDV offers a marginal absolute error rate reduction of 0.26%, i.e. a need to perform complete SDV of about 370 data points to avoid one unspecified error and does not support complete SDV as a means of providing meaningful improvements in data accuracy.
| S-EPMC4386950 | biostudies-literature
Project description:Data from the Google search engine enables the assessment of Google users' interest in a specific topic. We analyzed the world trends in searches associated with the topics "antibiotics" and "probiotics" from January 2004 to June 2019, using Google Trends. We analyzed the yearly trends and seasonal variation. We performed an R-Spearman rank correlation analysis of the relative search volume (RSV) of the topics in 2015 with antibiotic consumption, health expenditure per capita, and the 2015 Human Development Index (HDI) of the country. The mean interest in the topic of antibiotics was equal to RSV = 57.5 ± 17.9, rising by 3.7 RSV/year (6.5%/year), while that of probiotics was RSV = 14.1 ± 7.9, which rose by 1.7 RSV/year (12.1%). The seasonal amplitude of antibiotics was equal to RSV = 9.8, while probiotics was RSV = 2.7. The seasonal peaks for both topics were observed in the cold months. The RSV of probiotics, but not antibiotics, was associated with antibiotic consumption (Rs = 0.35; p < 0.01), health expenditure (Rs = 0.41; p < 0.001), and HDI (Rs = 0.44; p < 0.001). Google users' interest in antibiotic- and probiotic-related information increases from year to year, and peaks in cold months. The interest in probiotic-related information might be associated with antibiotic consumption, health expenditure, and the development status of the Google users' country.
| S-EPMC6784173 | biostudies-literature
Project description:The evaluation of probiotics' efficacy in treating irritable bowel syndrome is supported by an increasing number of clinical studies based on a heterogeneous approach of products tested and the patient cohort involved. Although the role of gut microbiota dysbiosis in IBS pathogenesis and the beneficial contribution of probiotics were demonstrated, a tool to discriminate symptom-specific strains and a personalised medicine protocol are still lacking. Thus, this study employs, for the first time, a method that combines the preferred reporting items for systematic reviews and meta-analysis and multi-criteria decision analysis methods in a structured decision-making tool to analyze the efficacy of probiotic mix, in order to identify the most effective formulation and to discriminate which probiotics are more efficient in treating different symptoms. The PRISMA methodology resulted in a qualitative and quantitative analysis of 104 clinical studies from 2011 to 2021, revealing a prevalence of Lactobacillus rhamnosus, Lactobacillus acidophilus, and Bifidobacterium animalis subsp. lactis. MCDA analysis showed that formulations based on Lactobacillus rhamnosus and Lactobacillus acidophilus have the highest efficacy, especially on quality of life, bloating, and abdominal pain. This methodological approach could become more specific by modelling clinical studies according to the age and gender of patients and probiotic strain.
| S-EPMC9268703 | biostudies-literature
Project description:Pluripotent stem cells (PSCs) hold great potential for novel therapeutic approaches to regenerate or replace functionally impaired tissues. Since the introduction of the induced pluripotent stem cell technology in 2006, the number of scientific publications on this topic has constantly been increasing. However, so far no therapy based on PSCs has found its way into routine clinical use. In this study, we examined research trends related to clinical trials involving PSCs based on data obtained from ClinicalTrials.gov, the ICTRP database from the World Health Organization, as well as from a search of all individual databases that are included in the ICTRP using a multistep search algorithm. Following a stringent inclusion/exclusion procedure 131 studies remained that could be classified as clinical trials involving PSCs. The magnitude of these studies (77.1%) was observational, which implies that no cells were transplanted into patients, and only a minority of studies (22.9%) were of an interventional study type. The number of clinical trials involving induced pluripotent stem cells (iPSCs, 74.8%) was substantially higher than the one involving embryonic stem cells (ESCs, 25.2%). However, the picture changes completely when focusing on interventional studies, where in the majority (73.3%) of cases ESCs were used. Interestingly, also the study duration was significantly shorter for interventional versus observational trials (p?=?0.002). When focusing on the geographical study regions, it became obvious that the greatest part of all observational trials was performed in the USA (41.6%) and in France (16.8%), while the magnitude of interventional studies was performed in Asian countries (China 36.7%, Japan 13.3%, South Korea 10.0%) and in the field of ophthalmology. In summary, these results indicate that only a limited number of trials were focusing on the actual transplantation of PSCs into patients in a rather narrow field of diagnoses. The future will tell us, if the iPSC technology will ultimately overcome the current challenges and will finally make its way into routine clinical use.
| S-EPMC7486930 | biostudies-literature