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. 2020 Sep 3:32:106269.
doi: 10.1016/j.dib.2020.106269. eCollection 2020 Oct.

Data on global analysis of clinical trials with probiotics

Theresia M G Dronkers  1 , Arthur C Ouwehand  2 , Ger T Rijkers  1   3
Affiliations

Data on global analysis of clinical trials with probiotics

Theresia M G Dronkers et al. Data Brief. .

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.

Keywords: Clinical trials; ClinicalTrials.gov; Probiotics; Registration.

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Conflict of interest statement

(1) The work for this article was co-funded by the International Probiotics Association (internationalprobiotics.org). (2) G.T. Rijkers and A.C. Ouwehand are members of the Scientific Advisory Board of the International Probiotics Association (http://internationalprobiotics.org/). A.C. Ouwehand is an employee of DuPont Nutrition and BioSciences, which manufactures and markets probiotics. (3) The authors declare that, apart from what is stated above, they have no competing financial interests or personal relationships which have, or could be perceived to have, influenced the work reported in this article.

Figures

Fig 1
Fig. 1
Timing of registration of clinical trials with probiotics. X-axis shows the difference (in days) between the date of registration of the clinical trial and the date of inclusion of the first participants. Positive numbers indicate that the trial was registered after completion of the study. Day 0 indicates the moment of inclusion of the first participant. 32% of the trials were registered before inclusion of the first participant.
Fig 2
Fig. 2
Timing of registration of clinical trials with probiotics. X-axis shows the difference (in days) between the date of registration of the clinical trial and the date of completion of the study. Positive numbers indicate that the trial was registered after completion of the study. Day 0 indicates the moment of inclusion of the first participant. 78% of the trials were registered before completion of the study.
Fig 3
Fig. 3
Trend analysis 1997-2017 of the moment of registration of clinical trials with probiotics. Year of registration at ClinicalTrials.gov on the X-axis. Y-axis shows the difference (in days) between the date of registration of the clinical trial and the date of inclusion of the first participant. Positive numbers indicate that the trial was registered after inclusion of the first participant. Broken vertical line indicates the year of introduction of ClinicalTrials.gov. Regression analysis R2=0.155101, F=63.88351, significance F=1.96E-14.
Fig 4
Fig. 4
Trend analysis 1999-2017 of the moment of registration of clinical trials with probiotics. Year of registration at ClinicalTrials.gov on the X-axis. Y-axis shows the difference (in days) between the date of registration of the clinical trial and the date of completion of the study. Positive numbers indicate that the trial was registered after completion of the study. Broken vertical line indicates the year of introduction of ClinicalTrials.gov. Regression analysis R2=0.1485531, F=60.7159, significance F=7.68E-14.
Fig 5
Fig. 5
Trend analysis of the number of participants in clinical trials with probiotics on gastrointestinal conditions (n=349) over the period 2000-2020. Year of registration at ClinicalTrials.gov on the X-axis, number of participants on the Y-axis. Broken line represents regression line. R2=0.00045882, F=0.159284, significance F=0.690061812.
Fig 6
Fig. 6
Trend analysis of the number of participants in clinical trials on gastrointestinal conditions (n=9731) over the period 2000-2020. Year of registration at ClinicalTrials.gov on the X-axis, number of participants on the Y-axis. Broken line represents regression line. R2=0,000104368, F=1,01550609, significance F=0,313612416.
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