Infant Colics Clinical Trial
Official title:
Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time
Infantile colic is one of the most commonly reported medical problems within the first three
months of life causing appreciable distress for both parents and pediatricians.
It appears that multiple independent origins might be involved: amongst them infant's
difficult temperament, inadequate mother-infant communication or maternal anxiety, transient
lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal
smoking during pregnancy or after delivery. Consequently, various treatment approaches have
been tried to alleviate this condition.
Recent studies have suggested that changes of intestinal microflora of a newborn may play an
important role in pathogenesis of infantile colic. Therefore, dietary supplementation with
probiotics has been proposed for the improvement of this condition.
Aim of the study is to evaluate the improvement of colics symptoms by the oral
administration of VSL#3 and the difference in the daily average crying time (measured with
parental diary) between end of treatment and baseline.
In this study, 62 infants will be enrolled and will receive 10 drops per day of VSL#3 or
Placebo according to randomization list. The study product will be supplied as a box
containing the oil bottle and a powder stick. The product should be stored refrigerated. On
the first day of supplementation, the mother will open the sachet, pour the contents into
the bottle and shake vigorously. A dropper is provided to count the drops. The suspension
must be shaken vigorously before every use. Compliance will be monitored by filling out a
diary.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02813772 -
Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic
|
N/A |