Prebiotics and Probiotics Ensure Infant Growth and Promote Gut Health Starter Formula Enriched in Prebiotics and Probiotics Ensures Normal Growth of Infants and Promotes Gut Health: A Randomized Clinical Trial

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Breastfed infants are better protected against infections than formula-fed infants. Why? Because breast milk stimulates the development of bifidobacteria in the baby’s gut, and this bifidobacterium-rich microbiota has an important immunoprotective effect.

New infant formulas attempt to incorporate some of the beneficial properties of breast milk. This includes the addition of prebiotics and probiotics, which can protect children against infections.

The Clinical Trial

A group of European researchers carried out a study titled “Starter Formula Enriched in Prebiotics and Probiotics Ensures Normal Growth of Infants and Promotes Gut Health: A Randomized Clinical Trial” to evaluate the effect of a test formula containing bovine milk-derived oligosaccharide and the probiotic Bifidobacterium animalis ssp lactis on the immune system.

The researchers enrolled 413 full-term infants and assigned them to either a test group that received the prebiotic-probiotic formula or a control group that received infant formula without prebiotics and probiotics. A reference group of 63 breastfed babies was also used as a comparison model.

Infants who experienced a life-threatening event during the study period, who were hospitalized for more than three days, who were introduced to complementary food before four months, or who did not feed exclusively with the assigned formulas during the study were taken out of the trial.

Both the test and control formulas contained enough proteins, carbohydrates, fats, vitamins, and minerals to support the normal growth of healthy infants from birth to six months of age. All study subjects received a follow-up formula without prebiotics and probiotics from six to twelve months, and the complementary food was introduced progressively starting between four and six months of life.

The researchers measured the mean incidence of diarrhea as well as all infections that included a fever over twelve months. Diarrhea was defined as three or more loose or watery stools in twenty-four hours. Fever was defined as a body temperature greater than 38°C at least once during twenty-four hours.

The parents and caretakers wrote reports on adverse effects, daily weight gain, length, head circumference, arm circumference, digestive tolerance, colics, fecal pH, fecal bacteria counts, and other statistics during different periods in the first year of life.


The incidence of diarrhea was not significantly different between the test group and the control group, or between the test group and the breastfed group. The number of infants who had febrile infections at six and twelve months was not significantly different between the formula-fed groups. The proportion of infants who suffered adverse effects related to infections was comparable between the two formula-fed groups. There were no important differences in growth ratio and stool characteristics between the test and control groups or between the formula-fed groups and the breastfed group.

The test formula was well tolerated, and it supported normal growth in comparison with the breastfed group and according to WHO growth standards. During the first month, infants in the test group tended to consume less formula than those in the control group, but this did not delay infant growth.

In addition to the higher bifidobacterium and lactobacilli counts in the test group, harmful bacteria counts and fecal pH were lower in the test group compared to the control group. This suggests that supplementation with prebiotics and probiotics promotes the development of potentially beneficial bacteria, making the gut microbiota more like the gut microbiota found in breastfed infants.

In conclusion, although supplementation of infant formulas with prebiotics and probiotics did not show a decrease in diarrhea rates, it did promote a beneficial microbiota composition much like that observed in breastfed infants. This result suggests that supplementation has a favorable effect on immune markers and gut milieu.

Although manufacturers of infant formulas continue to produce better substitutes for breast milk, breast milk is still the best food for children. Consult a pediatrician for guidance and help.


Radke, Michael, Jean-Charles Picaud, Andrea Loui, Gilles Cambonie, Dirk Faas, Harry N. Lafeber, Nanda de Groot, Sophie S. Pecquet, Philippe G. Steenhout, and Jean-Michel Hascoet. “Starter Formula Enriched in Prebiotics and Probiotics Ensures Normal Growth of Infants and Promotes Gut Health: A Randomized Clinical Trial.” Pediatric Research 81, no. 4 (2017): 622. Retrieved from

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