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Data on global analysis of clinical trials with probiotics.

ABSTRACT: Data on characteristics of clinical trials with probiotics, registered at ClinicalTrials.gov were retrieved from the registry . Data on the registration process itself (moment of registration of the trial in relation to date of inclusion of first participant, data of completion of the study) as well as the number of participants were analysed. A trend analysis (over the period 2000-2020) was made of the number of participants in clinical trials with probiotics on gastrointestinal conditions and diseases. A comparison was made between conditions and diseases studied in completed clinical trials with those trials not yet recruiting participants. The data can be used and reused for assessment of the quality of clinical studies with probiotics and to identify future trends in applications of probiotics.

SUBMITTER: Dronkers TMG

PROVIDER: S-EPMC7490816 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Data on global analysis of clinical trials with probiotics.

Dronkers Theresia M G TMG Ouwehand Arthur C AC Rijkers Ger T GT

Data in brief 20200903

Data on characteristics of clinical trials with probiotics, registered at ClinicalTrials.gov were retrieved from the registry . Data on the registration process itself (moment of registration of the trial in relation to date of inclusion of first participant, data of completion of the study) as well as the number of participants were analysed. A trend analysis (over the period 2000-2020) was made of the number of participants in clinical trials with probiotics on gastrointestinal conditions and ...[more]

PMID: 32964082

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Project description:BackgroundWith the disappointing results associated with the use of cardiac myosin inhibitors in the treatment of hypertrophic cardiomyopathy (HCM), the development of new therapies in clinical trials for HCM has rapidly increased. We assessed the characteristics of therapeutic intervention in HCM registered on ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP).MethodsWe conducted a cross-sectional, descriptive study of clinical trials for therapeutic intervention in HCM registered on ClinicalTrials.gov and ICTRP.ResultsThis study analyzed 137 registered trials. Regarding study designs of these trials, 77.37% were purpose of treatment, 59.12% were randomized, 50.36% were parallel assignment, 45.26% were performed with masking, 48.18% recruited less than 50 participants, and 27.74% were Phase 2 trials. In total, 67 trials were new drug trials, of which 35 drugs were tested in these trials, and 13 trials involved treatment with mavacamten. Of these 67 clinical drug trials, 44.78% of trials involved the study of amines, and 16.42% involved 1-ring heterocyclic compounds. Regarding the NCI Thesaurus Tree, 23.81% of trials involved myosin inhibitors, 23.81% of trials involved drugs belonging to agents affecting the cardiovascular system, and 20.63% were involved in testing cation channel blockers. The drug-target network showed that myosin-7, potassium voltage-gated channel subfamily h member 2, beta-1 adrenergic receptor, carnitine o-palmitoyltransferase 1, and liver isoform were the most targeted pathways of the clinical trials analyzed in the drug-target network.ConclusionThe number of clinical trials investigating therapeutic interventions for HCM has increased in recent years. Ultimately, recent HCM therapeutic clinical trials generally did not incorporate either randomized controlled trials or masking and were small studies recruiting fewer than 50 participants. Although recent research has focused on targeting myosin-7, the molecular signaling mechanisms involved in the pathogenesis of HCM have the potential to elucidate novel target pathways.

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.

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Data on global analysis of clinical trials with probiotics.

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Data on global analysis of clinical trials with probiotics.

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