Impact of Probiotic Preparation VSL#3 on Infants Colics
|ClinicalTrials.gov Identifier: NCT01869426|
Recruitment Status : Unknown
Verified April 2015 by Prof. Maria Elisabetta Baldassarre, Policlinico Hospital.
Recruitment status was: Recruiting
First Posted : June 5, 2013
Last Update Posted : May 1, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Infant Colics||Dietary Supplement: VSL#3 drops Dietary Supplement: VSL#3 drops placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||October 2015|
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|
- Improvement of colics symptoms [ Time Frame: 3 weeks ]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 ]Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|