Infantile Colic Clinical Trial
Official title:
Randomized Clinical Trial to Evaluate the Efficacy of Bifidobacterium in the Treatment of Infantile Colic (IC)
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.
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