Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background: Colic is a common condition in infants <4 months of age. Attempts to treat infantile colic with probiotics have shown variable efficacy and overall low evidence of success. In this work, we tested the hypothesis that oral administration of Bifidobacterium longum CECT7894 (KABP042) and Pediococcus pentosaceus CECT8330 (KABP041) mix (1 × 109 colony forming units) would improve the symptoms of infantile colic. Methods: A total of 112 exclusively breastfed or mixed fed infants aged <2 months and meeting the ROME IV criteria for infantile colic were recruited. The infants were randomized in a double-blind, placebo-controlled trial to receive orally administered probiotics (intervention group, IG, n = 48) or placebo (placebo group, PG, n = 42) daily for 21 days. Results: Infants in the IG had significantly shorter crying time (p < 0.001) on day 7 [IG vs. PG, median (25-75th percentile): 38 (3.5-40.5) vs. 62 (40-108) min/day], day 14 [IG vs. PG: 20 (0-40) vs. 50 (30-75) min/day], and day 21 [IG vs. PG: 14 (0-33) vs. 40 (28-62) min/day]. Higher responder ratio and fewer crying/fussing episodes on days 7, 14, and 21 and better stool consistency on day 21 were observed in the IG (p < 0.01) as compared to the PG. Conversely, no significant effects on stool frequency or quality of life were observed. Conclusions: In summary, daily oral administration of B. longum CECT7894 (KABP042) and P. pentosaceus CECT8330 (KABP041) was an effective treatment for shortening crying time due to infantile colic and for improving fecal consistency. This trial was registered retrospectively in December 2019 with a trial number of ISRCTN92431452.

Keywords: Bifidobacterium longum CECT7894; Pediococcus pentosaceus CECT8330; fecal consistency; infantile colic; infants; probiotics.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. AB-Biotics SA (Barcelona, Spain) is the company owning worldwide IP rights of the probiotic strains used in this research and PROCEMSA Spa (Nichelino, Italy) is a toll manufacturer employed by AB-BIOTICS SA. These two companies did not participate in study funding, design, data collection, analysis, and interpretation, or in writing the manuscript. Maternal and Infant Health and Care Science Laboratory (Shanghai, China) holds an interest in the distribution of the probiotic used in this study in China, but its contribution was limited to funding the study and publication, and did not participate in study design, data collection, analysis, and interpretation, or in writing the manuscript. The authors are not employed by any of the aforementioned companies nor hold their shares. The companies did not compensate for time and efforts of the authors in cash or kind for conducting this study.

Copyright © 2021 Chen, Liu, Li, Lei, Zeng, Xu, Li and Savino.

Figures

Figure 1

Diagram of patient enrollment and study progress.

Figure 2

Effect of intervention on crying/fussing time (left) and number of crying/fussing episodes (right). P-values correspond to Kruskal-Wallis test performed at each timepoint. Box and whiskers denote quartiles and 95% percentiles.