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Clinical trials of baby formula are not credible

An international team of scientists led by dr Bartosz Helfer, Head of the Academic Excellence Hub – Meta Research Centre, conducted a systematic review evaluating the way the research on baby formula is carried out and reported. The scientists have determined that recent research lacks scientific rigour. An urgent improvement of the tests is needed, to protect the consumers from misleading information.

Clinical trials of baby formulas bear the risk of being biased, their authors almost always publish positive conclusions, the research lacks clarity and its findings are reported selectively.

Baby formula is consumed in big quantities by most infants in Europe and North America, and new products must be tested in clinical trials before being admitted to the market. However, some fear has arisen that the clinical trials are biased and may undermine breastfeeding.

To investigate further an international team of scientists decided to evaluate the way the studies on the baby formula are conducted and reported. The scientists were especially interested in understanding the risk of bias in published articles and whether the scientific procedures in randomized clinical trials may be harmful by undermining breastfeeding in participants.

The scientists conducted an analysis of 125 studies published since 2015, in which at least two baby formula products were compared, in 23 757 children under three years old.

The trials were conducted mainly in Europe (42%), Asia (28%) or North America (18%). The most common measures were weight gain (36%), intestinal health (26%), absorption of nutrients (10%), change of behaviour (6%) and allergies (6%).

The scientists discovered that only 17 (14%) of the trials were conducted independently of the companies producing baby formula, 26 (21%) were registered with a clear prospect and the main result, and 11 (9%) had a report publicly available.

Most (80%) of the trials represented a high risk of bias of the main result, usually because of an improper way of excluding participants from the analysis, and selective reporting (for instance, when the findings were not fully or accurately presented in order to suppress negative or unwanted results).

In over 90% of trials the authors reported positive findings for publication.

Even though the systematic report conducted by dr Helfer with colleagues uses the best available tools, the scientists admit that because the results of numerous trials of baby formula are not publicly available, their findings might not fully represent all trials conducted in the field.

“The baby formula industry is closely engaged with the trials, the findings are almost always presented as beneficial and the goals of research or reporting the findings have low clarity” – write dr Helfer and colleagues. “Our conclusions confirm the need for a major change in the way the trials are conducted and reported, to protect their participants in the harm caused by suppressing breastfeeding and the consumers from misleading information”.

The systematic report was published in the BMJ and its full text is available for everyone at:

The above summary is an adaptation of the press materials created by the BMJ.

Translated by Patrycja Śliwińska (student of English Studies at the University of Wrocław) as part of the translation practice.

Published by: Maria Kozan

2 Dec 2021

last modification: 2 Dec 2021