Study explores efficacy of probiotics in colicky infants

By Stephen Daniells

- Last updated on GMT

© reewungjune / Getty Images
© reewungjune / Getty Images
A combination of Bifidobacterium longum and Pediococcus pentosaceus strains may reduce crying and fussing time compared to the most studied probiotic for infant colic, says a new study.

Data published in the European Journal of Pediatrics ​indicated that daily supplementation with B. longum​ KABP042 + P. pentosaceus​ KABP041 led to better response rates after seven and 14 days, compared to Limosilactobacillus reuteri​ DSM17938 (formerly Lactobacillus reuteri​), cited to be the most documented probiotic for infant colic.

The study was funded by Spain-based AB-Biotics SA (Kaneka Group).

“This study marks a potential step-change for the symptom support of colicky infants. L. reuteri​ DSM17938 is demonstrated to be effective in the study, but the combination of Bifidobacterium longum​ KABP-042 and Pediococcus pentosaceus​ KABP-041 is significantly more effective in reducing crying time,” said Jordi Espadaler, director of innovation at AB-Biotics and co-author on the new paper.

“To us, bringing probiotics to life means advancing the field of probiotics with improved or alternative solutions for consumers worldwide. In this latest study, we wanted to examine our probiotic solution for infant colic treatment, not just in their inherent ability to relieve symptoms but to bolster the evidence for newer solutions compared to the established norms.”

1 in 4 infants worldwide suffers from colic

Colic is defined as severe pain in the abdomen caused by wind or obstruction in the intestines and suffered especially by babies. Characterized by excessive crying, grimacing, a red face, knees drawn up to the chest, clenched fists and excessive gas, the answer seems to lie in the gut. It is one of the most common reasons parents seek medical advice during the first three months of their baby’s life.

Babies with colic have lower counts of good bacteria and increased concentrations of undesirable bacteria in their digestive tracts. This has led to multiple studies using probiotics to impact measures of colic.

The new study builds on earlier work from AB-Biotics/Kaneka Probiotics that was published in Frontiers of Microbiology​ in 2022​. Results from that pilot study indicated that B. longum​ KABP042 + P. pentosaceus​ KABP041 improved measures of functional gastrointestinal disorders (FGIDs) in infants, including colic and constipation.

The new study is reported to be the “first comparative randomized controlled study on infant colic using such active comparator [BioGaia’s L. reuteri​ DSM17938]”.

Study details

The new randomized, multi-center, parallel, single-blind study included 112 colicky infants. The children were randomly assigned to receive either 1 billion CFUs per day of B. longum​ KABP042 + P. pentosaceus​ KABP041 (known commercially as AB-Kolicare) or 100 million CFUs per day of L. reuteri​ DSM17938 for 21 days.

When asked by NutraIngredients-USA about the differences in the doses, a spokesperson for AB-Biotics/ Kaneka Probiotics explained that 100 million CFUs is the clinical dose of L. reuteri​ DSM17938​.  

“The comparison was between the clinical dose of each probiotic respectively,” the source said.

The results showed a significantly greater decreases in crying and fussing time and faster relief in the combination group across all timepoints versus L. reuteri​.

Specifically, before supplementation, average crying time for both groups was registered at 270 minutes per day. However, after seven days, crying time averaged 180 minutes with L. reuteri​ DSM17938 (registering a reduction of 90 minutes) and 120 minutes with the B. longum​ KABP-042 and P. pentosaceus​ KABP-041 blend (registering a reduction of 150 minutes).

The benefits from administering the probiotic were seen regardless of whether babies were breastfed or formula-fed, the researchers noted.

“This study is the culmination of years of dedicated research and development by our team of experts,” said Sergi Audivert, executive director and co-founder at AB-Biotics. “Our unprecedented trial comparing the established support for infant colic with our new probiotic solution not only strengthens the position of our probiotic for colic as the most effective probiotic for colic but supports our ultimate goal to increase the quality of research around probiotics for infants, ensuring we strive to further alleviate the severity of functional gastrointestinal disorders globally.”

Source: European Journal of Pediatrics
doi: 10.1007/s00431-024-05806-x
“Comparative efficacy of probiotic mixture Bifdobacterium longum​ KABP042 plus Pediococcus pentosaceus​ KABP041 vs. Limosilactobacillus  reuteri​ DSM17938 in the management of infant colic: a randomized  clinical trial”
Authors: J. M. Moreno‑Villares, et al.

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