Status:
UNKNOWN
Impact of Probiotic Preparation VSL#3 on Infants Colics
Lead Sponsor:
Policlinico Hospital
Conditions:
Infant Colics
Eligibility:
All Genders
30-90 years
Phase:
PHASE4
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01869426
Start Date
June 1 2013
End Date
October 1 2015
Last Update
May 1 2015
Active Locations (1)
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1
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, Italy, 70124