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

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 success. In this work, we tested the hypothesis that oral administration Bifidobacterium longum CECT7894 (KABP042) Pediococcus pentosaceus CECT8330 (KABP041) mix (1 × 10 9 colony forming units) would improve symptoms colic. Methods: A total 112 exclusively breastfed or mixed fed aged <2 meeting ROME IV criteria for were recruited. The randomized double-blind, placebo-controlled trial receive orally administered (intervention group, IG, n = 48) placebo (placebo PG, 42) daily 21 days. Results: Infants IG had significantly shorter crying time ( p < 0.001) on day 7 [IG vs. median (25?75th percentile): 38 (3.5–40.5) 62 (40–108) min/day], 14 PG: 20 (0–40) 50 (30–75) (0–33) 40 (28–62) min/day]. Higher responder ratio fewer crying/fussing episodes days 7, 14, better stool consistency observed 0.01) as compared PG. Conversely, no significant effects frequency quality life observed. Conclusions: summary, B. P. was an effective treatment shortening due improving fecal consistency. This registered retrospectively December 2019 number ISRCTN92431452.