Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula : a systematic review

dc.contributor.authorMugambi, Mary N.
dc.contributor.authorMusekiwa, Alfred
dc.contributor.authorLombard, Martani
dc.contributor.authorYoung, Taryn
dc.contributor.authorBlaauw, Renee
dc.date.accessioned2014-02-07T12:19:43Z
dc.date.available2014-02-07T12:19:43Z
dc.date.issued2013-11
dc.descriptionPublication of this article was funded by the Stellenbosch University Open Access Fund.en_ZA
dc.descriptionThe original publication is available at http://www.biomedcentral.com/1471-2288/13/137en_ZA
dc.description.abstractBackground: There is little or no information available on the impact of funding by the food industry on trial outcomes and methodological quality of synbiotics, probiotics and prebiotics research in infants. The objective of this study was to compare the methodological quality, outcomes of food industry sponsored trials versus non industry sponsored trials, with regards to supplementation of synbiotics, probiotics and prebiotics in infant formula. Methods: A comprehensive search was conducted to identify published and unpublished randomized clinical trials (RCTs). Cochrane methodology was used to assess the risk of bias of included RCTs in the following domains: 1) sequence generation; 2) allocation concealment; 3) blinding; 4) incomplete outcome data; 5) selective outcome reporting; and 6) other bias. Clinical outcomes and authors’ conclusions were reported in frequencies and percentages. The association between source of funding, risk of bias, clinical outcomes and conclusions were assessed using Pearson’s Chi-square test and the Fisher’s exact test. A p-value < 0.05 was statistically significant. Results: Sixty seven completed and 3 on-going RCTs were included. Forty (59.7%) were funded by food industry, 11 (16.4%) by non-industry entities and 16 (23.9%) did not specify source of funding. Several risk of bias domains, especially sequence generation, allocation concealment and blinding, were not adequately reported. There was no significant association between the source of funding and sequence generation, allocation concealment, blinding and selective reporting, majority of reported clinical outcomes or authors’ conclusions. On the other hand, source of funding was significantly associated with the domains of incomplete outcome data, free of other bias domains as well as reported antibiotic use and conclusions on weight gain. Conclusion: In RCTs on infants fed infant formula containing probiotics, prebiotics or synbiotics, the source of funding did not influence the majority of outcomes in favour of the sponsors’ products. More non-industry funded research is needed to further assess the impact of funding on methodological quality, reported clinical outcomes and authors’ conclusions.en_ZA
dc.description.sponsorshipStellenbosch Universityen_ZA
dc.description.versionPublishers' versionen_ZA
dc.format.extent22 p.
dc.identifier.citationMugambi, M.N. et al. 2013.Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula: A systematic review. BMC Medical Research Metholodogy, 13:137, doi:10.1186/1471-2288-13-137.en_ZA
dc.identifier.issn1471-2288 (print)
dc.identifier.issn1471-2288 (online)
dc.identifier.otherdoi:10.1186/1471-2288-13-137
dc.identifier.urihttp://hdl.handle.net/10019.1/86124
dc.language.isoen_ZAen_ZA
dc.publisherBioMed Centralen_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectSynbiotics -- Researchen_ZA
dc.subjectProbiotics -- Researchen_ZA
dc.subjectPrebiotics -- Researchen_ZA
dc.subjectInfant formulas -- Researchen_ZA
dc.titleAssociation between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula : a systematic reviewen_ZA
dc.typeArticleen_ZA
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