Clinical trial NCT01869426: Impact of Probiotic Preparation VSL#3 on Infants Colics
Official title: Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infant Colics
Keywords: colics
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Infants aged between 30 and 90 days
* Breast fed exclusively during length of trial
* Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week but not treated previously for colics.
* Debut of colic symptoms 6+/-1 days before randomization
* Written informed consent from one or both parents
* Stated availability and reliability throughout the study period.

Exclusion Criteria:

* Major chronic disease
* Gastrointestinal disease
* Administration of antibiotics the week before randomization
* Administration of probiotics two weeks before randomization
* Infants with GI malformation, cystic fibrosis, other genetic diseases
* Participation in other clinical trials.

Primary outcomes:
measure: Improvement of colics symptoms
timeFrame: 3 weeks
Secondary outcomes:
measure: Difference in the daily average crying time between end of treatment and baseline.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Mariella Baldassarre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baldassarre ME, Di Mauro A, Tafuri S, Rizzo V, Gallone MS, Mastromarino P, Capobianco D, Laghi L, Zhu C, Capozza M, Laforgia N. Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis. Nutrients. 2018 Feb 10;10(2):195. doi: 10.3390/nu10020195.