Infant Colics | Impact of Probiotic Preparation VSL#3 on Infants Colics
Infant Colics research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:VSL#3 drops
Dietary Supplement:VSL#3 drops placebo
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
VSL#3 drops31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days.
VSL#3 drops placebo31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days.
Start Date: June 2013
Completed Date: October 2015
Phase: Phase 4
Primary Outcome: Improvement of colics symptoms
Secondary Outcome: Difference in the daily average crying time between end of treatment and baseline.
Study sponsors, principal investigator, and references
Principal Investigator: Mariella Baldassarre, PhD
Lead Sponsor: Policlinico Hospital