Impact of Probiotic Preparation VSL#3 on Infants Colics

Infant Colics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01869426
• Other study ID #: VSLcolics13
• Status: Recruiting
• Phase: Phase 4
• First received: May 28, 2013
• Last updated: April 30, 2015
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: April 2015
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infant Colics

Intervention

Dietary Supplement:
• VSL#3 drops

• VSL#3 drops placebo

Locations

Country	Name	City	State
Italy	Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of colics symptoms	improvement of colics symptoms by the oral administration of probiotic VSL#3 drops	3 weeks	No
Secondary	Difference in the daily average crying time between end of treatment and baseline.	Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.	3 weeks	No