NCT02988791

Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 1 Week – 7 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotic (BIfidobacterium, BB-12®)	probiotic (Bifidobacterium, BB-12®)
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-09-01
• Completion: 2018-05-01
• First posted: 2016-12-09
• Last updated: 2019-04-16

Locations

1 site across 1 country: Italy