Impact of Probiotic Preparation VSL#3 on Infants Colics
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.
Dietary Supplement: VSL#3 drops
Dietary Supplement: VSL#3 drops placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time|
- Improvement of colics symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]improvement of colics symptoms by the oral administration of probiotic VSL#3 drops
- Difference in the daily average crying time between end of treatment and baseline. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: VSL#3 drops
31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days.
|Dietary Supplement: VSL#3 drops|
Placebo Comparator: VSL#3 drops placebo
31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days.
|Dietary Supplement: VSL#3 drops placebo|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869426
|Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital||Recruiting|
|Bari, Italy, 70124|
|Contact: Maria Elisabetta Baldassarre, PhD +393296114818 firstname.lastname@example.org|
|Principal Investigator: Maria Elisabetta Baldassarre, PhD|
|Principal Investigator:||Mariella Baldassarre, PhD||Policlinico Hospital|