Completed
NA
INTERVENTIONAL
NCT03434249
Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.
Interventions
Name:
Bifidobacterium, BB-12® (Bifidolactis Infant)
Type:
DIETARY_SUPPLEMENT
Description:
Name:
Bifidolactis Infant Placebo
Type:
DIETARY_SUPPLEMENT
Description:
Primary Outcomes
Measure:
Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
TimeFrame:
at 28 days from the baseline (Visit T5)
Description:
Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary.
Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well.
The following categories of patients has been defined:
Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)
Trial Information
NCT ID
NCT03434249
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
SOFAR S.p.A.
Last Updated
December 15, 2025