Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months: paroxysms of irritability, fussing, or crying that start and stop without obvious cause; episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least 1 week; and no failure to thrive. The condition is very common in the first 4 months of life (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive and inconsolable crying without an identifiable cause. Infantile colic cause considerable stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all pediatric visits in the first 4 months of life) and frequent formula changes. The pathophysiology of IC is still poorly defined, but differences in gut microbiota composition seem to be involved. In particular, differences in the number and species of Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects with IC, and it has been postulated that these alterations could be responsible for an abnormal gas production within gut lumen resulting in distension and abdominal pain. These findings suggest the potential role of probiotics as preventive and therapeutic strategy for the IC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
probiotic (Bifidobacterium, BB-12®)
Placebo
University of Naples Federico II
Naples, Italy
mean daily crying duration
reduction of ≥50% of mean daily crying duration
Time frame: up to 28 days
number of regurgitation
Time frame: up to 28 days
Evaluation of the gut microbiota modifications
Stool sample
Time frame: up to 28 days
fecal production of peptides from innate immune system
Stool sample
Time frame: up to 28 days
fecal short chain fatty acids production
Stool sample
Time frame: 28 days
evacuative frequency
Time frame: up to 28 days
consistency of the fecal mass
assessed by means of Bristol score
Time frame: up to 28 days
number of crying episode
Time frame: up to 28 days
sleep
duration of sleep
Time frame: up to 28 days
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