Impact of Probiotic Preparation VSL#3 on Infants Colics

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Policlinico Hospital
Sponsor:
Information provided by (Responsible Party):
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01869426
First received: May 28, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Infant Colics
Dietary Supplement: VSL#3 drops
Dietary Supplement: VSL#3 drops placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time

Further study details as provided by Policlinico Hospital:

Primary Outcome Measures:
  • Improvement of colics symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    improvement of colics symptoms by the oral administration of probiotic VSL#3 drops


Secondary Outcome Measures:
  • Difference in the daily average crying time between end of treatment and baseline. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.


Estimated Enrollment: 62
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869426

Locations
Italy
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital Recruiting
Bari, Italy, 70124
Contact: Maria Elisabetta Baldassarre, PhD    +393296114818    mariellabaldassarre@gmail.com   
Principal Investigator: Maria Elisabetta Baldassarre, PhD         
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Mariella Baldassarre, PhD Policlinico Hospital
  More Information

No publications provided

Responsible Party: Prof. Maria Elisabetta Baldassarre, Professor of Pediatrics, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01869426     History of Changes
Other Study ID Numbers: VSLcolics13
Study First Received: May 28, 2013
Last Updated: January 9, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Policlinico Hospital:
colics

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 18, 2014