Impact of Probiotic Preparation VSL#3 on Infants Colics

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

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.

Study Overview

• Status: Unknown
• Conditions: Infant Colics
• Intervention / Treatment: Dietary supplement: VSL#3 drops; Dietary supplement: VSL#3 drops placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
    • Contact: Maria Elisabetta Baldassarre, PhD; Phone Number: +393296114818; Email: mariellabaldassarre@gmail.com
    • Principal Investigator: Maria Elisabetta Baldassarre, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of colics symptoms	improvement of colics symptoms by the oral administration of probiotic VSL#3 drops	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Policlinico Hospital
• Investigators: Principal Investigator: Mariella Baldassarre, PhD, Policlinico Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 31, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: colics
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: VSLcolics13