Clinical Trial: Impact of Probiotic Preparation VSL#3 on Infants Colics

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Policlinico Hospital

Current Primary Outcome: Improvement of colics symptoms [ Time Frame: 3 weeks ]

improvement of colics symptoms by the oral administration of probiotic VSL#3 drops


Original Primary Outcome: Same as current

Current Secondary Outcome: Difference in the daily average crying time between end of treatment and baseline. [ Time Frame: 3 weeks ]

Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.


Original Secondary Outcome: Same as current

Information By: Policlinico Hospital

Dates:
Date Received: May 28, 2013
Date Started: June 2013
Date Completion: October 2015
Last Updated: April 30, 2015
Last Verified: April 2015