Finally, to ensure high methodological quality, outcome measures with established reliability and validity have been selected.
We included all studies meeting these criteria irrespective of study design, methodological quality or outcomes measured.
All the included trials were assessed for methodological quality and outcomes of interest using a standardized form [ 12].
The objective of this systematic review was to compare the methodological quality and outcomes of food industry sponsored trials versus non industry sponsored trials with regards to supplementation of synbiotics, probiotics and prebiotics in infant formula.
These studies reported some positive effects, but the results were based on small sample sizes, and, in the trial of insufficient methodological quality, the outcomes may also have been affected by the large drop-out rate and the dissimilarity of the study groups at baseline.
However, similar to other systematic reviews, it is limited by the methodological quality and outcome reporting of the included studies.
We undertook a sensitivity analysis to explore the robustness of our findings, including the trial size, duration of follow-up, differences in method of assessing the primary outcome, and differences in methodological quality (blinding of outcome assessors) of the included trials.
Two authors extracted the following data: the basic characteristics of patients, the methodological quality and clinical outcomes from the included RCTs independently.
More non-industry funded research is needed to further assess the impact of funding on methodological quality, reported clinical outcomes and authors' conclusions.
Majority of RCTs were industry funded, more non-industry funded research is needed to further assess the impact of funding on methodological quality, reported clinical outcomes and authors' conclusions.
