Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota
Authors: Maria Elisabetta Baldassarre
Journal: Annals of Internal Medicine (2019)

Letters15 January 2019Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying MicrobiotaMaria Elisabetta Baldassarre, MDMaria Elisabetta Baldassarre, MDAldo Moro University of Bari, Bari, Italy (M.E.B.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/L18-0561 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:I read with interest Bafeta and colleagues' article (1) that concluded that harms reporting for probiotics, prebiotics, and synbiotics is often lacking or inadequate. The authors also should have mentioned that probiotic identification generally limited at the species level or by trademark is an additional aggravating factor.The European Society for Paediatric Gastroenterology, Hepatology, and Nutrition recently advocated for more stringent quality control of probiotics and noted that "Procedures such as fermentation, matrix composition, cell harvesting, spray drying, freeze-drying and storage conditions like temperature, humidity and pH, are just several out of a wider array of manufacturing ...References1. Bafeta A, Koh M, Riveros C, Ravaud P. Harms reporting in randomized controlled trials of interventions aimed at modifying microbiota: a systematic review. Ann Intern Med. 2018;169:240-7. [PMID: 30014150]. doi:10.7326/M18-0343 LinkGoogle Scholar2. Kolacek S, Hojsak I, Berni Canani R, Guarino A, Indrio F, Orel R, et al; ESPGHAN Working Group for Probiotics and Prebiotics.. Commercial probiotic products: a call for improved quality control. A position paper by the ESPGHAN working group for probiotics and prebiotics. J Pediatr Gastroenterol Nutr. 2017;65:117-24. [PMID: 28644359] doi:10.1097/MPG.0000000000001603 CrossrefMedlineGoogle Scholar3. de Simone C. The unregulated probiotic market. Clin Gastroenterol Hepatol. 2018. [PMID: 29378309] doi:10.1016/j.cgh.2018.01.018 CrossrefMedlineGoogle Scholar4. Baldassarre ME, Di Mauro A, Mastromarino P, Fanelli M, Martinelli D, Urbano F, et al. Administration of a multi-strain probiotic product to women in the perinatal period differentially affects the breast milk cytokine profile and may have beneficial effects on neonatal gastrointestinal functional symptoms. A randomized clinical trial. Nutrients. 2016;8. [PMID: 27801789] CrossrefMedlineGoogle Scholar5. Biagioli M, Laghi L, Carino A, Cipriani S, Distrutti E, Marchianò S, et al. Metabolic variability of a multispecies probiotic preparation impacts on the anti-inflammatory activity. Front Pharmacol. 2017;8:505. [PMID: 28804459] doi:10.3389/fphar.2017.00505 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Aldo Moro University of Bari, Bari, Italy (M.E.B.)Disclosures: The author has disclosed no conflicts of interest. The form can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L18-0561. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoHarms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota Aïda Bafeta , Mitsuki Koh , Carolina Riveros , and Philippe Ravaud Harms Reporting in Randomized Controlled Trials of Interventions Aimed at Modifying Microbiota Aïda Bafeta , Mitsuki Koh , Carolina Riveros , and Philippe Ravaud Metrics Cited byImpact of probiotics supplement on the gut microbiota in neonates with antibiotic exposure: an open-label single-center randomized parallel controlled studyDysbiosis and Prematurity: Is There a Role for Probiotics?Cow's Milk Allergy: Immunomodulation by Dietary InterventionManagement of STEC Gastroenteritis: Is There a Role for Probiotics? 15 January 2019Volume 170, Issue 2Page: 143KeywordsConflicts of interestDisclosureGastroenterology and hepatologyHumidityNutritionPregnancyProbioticsQuality improvementSafetyTemperature ePublished: 15 January 2019 Issue Published: 15 January 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...