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.
However, similar to other systematic reviews, it is limited by the methodological quality and outcome reporting of the included studies.
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.
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 reviewers independently agreed on eligibility; three reviewers independently assessed methodological quality and extracted outcome data.
We therefore chose to summarise the results by means of a qualitative analysis using a rating system that consists of five levels of scientific evidence, taking into account the methodological quality and the outcome of the original studies (best-evidence synthesis) (Table 2) [ 20]. * Consistent findings were defined as ≥75% of the trials showing results in the same direction.
Two authors extracted the following data: the basic characteristics of patients, the methodological quality and clinical outcomes from the included RCTs independently.
