NCT01869426

Impact of Probiotic Preparation VSL#3 on Infants Colics

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Policlinico Hospital · Academic / Other
• Sex: All
• Age: 30 Days – 90 Days
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Infant Colics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VSL#3 drops
DIETARY_SUPPLEMENT	VSL#3 drops placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2013-06-05
• Last updated: 2015-05-01

Locations

1 site across 1 country: Italy