Crying Clinical Trial
Official title:
A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic
The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.
Infantile colic ıs one of the most common problems within the first 3 months of life,
affecting as many as 3% to 28% of newborn children. It consists of a behavioral syndrome
characterized by paroxysmal, excessive, inconsolable crying without identifiable cause.
Lactobacillus reuteri, one of the few endogenous lactobacillus species in the human
gastrointestinal tract, has been used safely for many years as a probiotic dietary
supplement in adults, and recent data demonstrated safety after long-term dietary
supplementation for newborn infants. The positive effects of this probiotic on intestinal
disorders such as constipation and diarrhea and in protection from infection,as well as its
capacity to modulate immune responses.
The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a
prospective randomized controlled study would improve symptoms of infantile colic.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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