Infantile Colic Clinical Trial
Official title:
Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).
The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.
The goal of this clinical trial is to evaluate the potential beneficial effects of a probiotic formulation on the symptoms of infantile colic. Participants diagnosed with infantile colic will be recruited to participate in this randomized, double-blind, placebo controlled, two-armed parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period. The study will consist of 3 in-person visits and 4 phone calls. ;
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