Comparison of Publication of Pediatric Probiotic vs Antibiotic Trials Registered on ClinicalTrials.gov

Riddell, Madison; Lam, Kaden; Funk, Anna; Lodha, Nidhi; Lorenzetti, Diane; Freedman, Stephen B.

doi:10.1001/jamanetworkopen.2021.25236

Cited by 4 publications

(4 citation statements)

References 52 publications

(107 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…First, prior research suggests risk of bias in the published studies on probiotics. 5,20 In the Cochrane review, 5 sensitivity meta-analyses of trials at low risk of bias did not show associations with mortality or infection and found smaller reductions in NEC risk (RR, 0.70 [95% CI, 0.55-0.89]), more in line with our findings. Second, patients enrolled in trials may differ systematically from patients treated in a NICU, although we found limited evidence of heterogeneity in the association between outcomes and probiotic adoption across neonate subgroups.…”

Section: Discussionsupporting

confidence: 86%

“…There are many reasons why probiotics may be less effective in practice than in published clinical trials. First, prior research suggests risk of bias in the published studies on probiotics . In the Cochrane review, sensitivity meta-analyses of trials at low risk of bias did not show associations with mortality or infection and found smaller reductions in NEC risk (RR, 0.70 [95% CI, 0.55-0.89]), more in line with our findings.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Association of Hospital Adoption of Probiotics With Outcomes Among Neonates With Very Low Birth Weight

et al. 2023

View full text Add to dashboard Cite

ImportanceFor neonates with very low birth weight (VLBW), randomized clinical trials (RCTs) indicate that probiotic treatment decreases the risk of necrotizing enterocolitis (NEC), with smaller decreases in the risk of sepsis and death. There is little evidence on the rate of probiotic adoption in US neonatal intensive care units (NICUs) and whether the benefits seen in trials have materialized in practice.ObjectiveTo estimate changes in probiotic use among neonates with VLBW and to test whether neonates with VLBW treated at NICUs adopting routine probiotic use experience better outcomes compared with neonates treated at nonadopting NICUs.Design, Setting, and ParticipantsThis cohort study used Vermont Oxford Network data on neonates with VLBW in US NICUs from January 1, 2012, to December 31, 2019. Data were analyzed from January 2022 through February 2023.ExposureProbiotics adoption vs nonadoption. Adopting NICUs were defined as those that currently or previously treated at least 20% of neonates with VLBW with probiotics.Main OutcomesThe primary outcomes were rates of NEC, in-hospital mortality, and sepsis, defined as bacterial or fungal infection occurring after day 3 from birth. A difference-in-differences analysis compared changes in VLBW infant outcomes between adopting and nonadopting NICUs before and after hospital-level adoption of probiotics. Additional analyses used the proportion of neonates treated with probiotics in each neonate’s birth NICU and year.ResultsThe analysis included 307 905 neonates with VLBW (mean [SD] gestational age, 28.4 [2.9] weeks; 50.0% male) at 807 US hospitals. The rate of probiotic treatment of neonates with VLBW rose from 1572 of 38 296 neonates (4.1%) in 2012 to 4788 of 37 910 (12.6%) in 2019. Only 123 of 745 NICUs (16.5%) adopted probiotics by 2019, with 4591 of 6017 neonates with VLBW (76.3%) receiving probiotics in 2019 at adopting NICUs. Incidence of NEC declined by 18% at adopting NICUs (odds ratio [OR], 0.82; 95% CI, 0.70-0.95; P = .10) compared with nonadopting NICUs. Probiotic adoption was not associated with a significant reduction in sepsis (OR, 1.11; 95% CI, 0.98-1.25; P = .09) or mortality (OR, 0.93; 95% CI, 0.80-1.08; P = .33).Conclusion and RelevanceIn this cohort study, adoption of routine use of probiotics increased slowly in US NICUs and was associated with lower NEC risk but not with sepsis or mortality among neonates with VLBW. The findings for probiotic adoption and NEC, sepsis, and mortality were smaller than would have been predicted by the totality of RCT evidence but are consistent with a meta-analysis restricted to studies at low risk of bias.

show abstract

Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Association of Hospital Adoption of Probiotics With Outcomes Among Neonates With Very Low Birth Weight

et al. 2023

View full text Add to dashboard Cite

show abstract

“…Fifth, it is important to consider the possibility of publication bias when interpreting our results. Notably, some researchers have suggested that probiotic trials are less likely to be published than antibiotic trials [35]. This highlights the need for the reporting and publication of high-quality scientifically valuable study results, whether positive or negative.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Bifidobacterium longum Supplementation in Infants: A Meta-Analysis of Randomized Controlled Trials

Guo,

Fan,

Hou

et al. 2023

Foods

View full text Add to dashboard Cite

Background: Strategies to stabilize and support overall infant health by increasing the number of Bifidobacterium longum in the infant gut are of interest, but few studies have systematically addressed this issue. We aimed to evaluate the efficacy and safety of Bifidobacterium longum use in infants using meta-analysis. Methods: We searched PubMed, EMBASE, Cochrane Library of Systematic Reviews, and SinoMed for publications until 27 July 2022. The main outcomes of interest were weight gain, risk of necrotizing enterocolitis (NEC), and adverse events. Two authors independently performed study screening, risk of bias assessment, and data extraction. Outcome data were extracted from each included study and combined using mean difference (MD) or risk ratio (RR) and finally combined using a fixed-effect model or random-effect model. Results: A total of 4481 relevant studies were identified, of which 15 were found to be eligible for randomized controlled trials and were included in the meta-analysis. The combined extracted data showed that the intervention group containing Bifidobacterium longum had a significantly lower risk of NEC (RR = 0.539, 95% CI: 0.333, 0.874) compared to the control group. There was no statistical difference between the intervention and control groups regarding weight gain (MD = 0.029, 95% CI: −0.032, 0.090), the occurrence of adverse events (RR = 0.986, 95% CI: 0.843, 1.153), and serious adverse events (RR = 0.881, 95% CI: 0.493, 1.573). Conclusions: Bifidobacterium longum may significantly reduce the risk of NEC in infants as well as being safe; thus, further research evidence is needed on whether there is a benefit on weight gain.

show abstract

“…Accessing the information on ClinicalTrials.gov is expected to provide valuable insights into the current state of research and potential areas for further analysis. Despite previous studies conducted in other fields (Chen et al, 2018;Wang et al, 2020;Riddell et al, 2021), the status of registered trials of anti-PD-1/ PD-L1 for NPC remains unknown.…”

Section: Introductionmentioning

confidence: 99%

Anti-PD-1/PD-L1 for nasopharyngeal carcinoma: a comprehensive analysis of registered trials on ClinicalTrials.gov

Dai,

Li,

Wang

et al. 2023

Front. Pharmacol.

View full text Add to dashboard Cite

Objective: Clinical trials play an important role in the development of healthcare. However, the current status of clinical trials on anti-PD-1/PD-L1 for nasopharyngeal carcinoma remains unclear. Therefore, this study aims to provide a comprehensive analysis of the registered trials related to anti-PD-1/PD-L1 for nasopharyngeal carcinoma on ClinicalTrials.gov.Methods: A search was conducted on the ClinicalTrials.gov database to identify all registered trials related to anti-PD-1/PD-L1 for nasopharyngeal carcinoma up to 26 February 2023. The characteristics of the trials were examined, and the studied drugs, disease conditions, as well as details of trials with available results were analyzed. Publication status was assessed by a PubMed search using the ClinicalTrials.gov NCT number.Results: A total of 112 interventional clinical trials registered between 2015 and 2023 were included. Of the trials, 90 were carried out in Asia, 72 were in phase 2, and 31 trials had either companies or universities as sponsors/collaborators. The sample sizes across the trials varied greatly, with a median of 71.5 participants per trial. The majority of trials were recruiting participants, with only 6 had posted results. PD-1 inhibitors were preferred over PD-L1, and Toripalimab emerged as the most extensively studied drug. About one-third (33.9%) of the studies looked into recurrent/metastatic nasopharyngeal cancer.Conclusion: This study provides an overview of all registered trials of anti-PD-1/PD-L1 for NPC. It is needed to improve the completeness, outcome selection, randomization and masking of trials and to be transparent and timely in reporting of results.

show abstract

Comparison of Publication of Pediatric Probiotic vs Antibiotic Trials Registered on ClinicalTrials.gov

Cited by 4 publications

References 52 publications

Association of Hospital Adoption of Probiotics With Outcomes Among Neonates With Very Low Birth Weight

Association of Hospital Adoption of Probiotics With Outcomes Among Neonates With Very Low Birth Weight

Efficacy and Safety of Bifidobacterium longum Supplementation in Infants: A Meta-Analysis of Randomized Controlled Trials

Anti-PD-1/PD-L1 for nasopharyngeal carcinoma: a comprehensive analysis of registered trials on ClinicalTrials.gov

Contact Info

Product

Resources

About