Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Mean change in crying time
Study Overview
Brief Summary
Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment.
We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo.
An interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.
Detailed Description
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. The reported incidence of infantile colic ranges from 3% to 28% in prospective studies and up to 40% in retrospective surveys.
The pathogenesis of infantile colic remains elusive despite decades of research. 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Days to 180 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy term infant 21-90 days of age
- •Birth weight ≥2500 g
- •Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
- •With colic symptoms (>3 hours of crying on >3 days per week) with debut 10 ± 5 days before enrollment
- •Gestational age between 37 and 42 weeks
- •Apgar score higher than 7 at 5 minutes
- •Written informed consent from a parent
Exclusion Criteria
- •Any chronic illness or gastrointestinal disorder as judged by the pediatrician
- •Any history of antibiotic treatment or probiotic supplementation
- •Failure to obtain a written consent by parent/legal guardian
- •Participation in other clinical trials
- •Infants with acute illness
- •Subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo
Outcomes
Primary Outcomes
Mean change in crying time
Time Frame: Baseline, 7 days, 14 days, 21 days
Reduction of daily median crying time (measured with parental diary) with L. reuteri DSM 17938 versus placebo at any of the time points 7, 14, and 21 days
Secondary Outcomes
- Number of responders vs. non-responders(Baseline, at 7, 14 and 21 days)
- Number of episodes of crying(Over 21 days)
- Parental quality of life(Daily for 21 days)
- Changes in stool consistency(Over 21 days)
- Duration of episodes of crying(Over 21 days)
Investigators
Gideon Koren
Director of MotherRisk Program, Clinical Pharmacology and Toxicology
The Hospital for Sick Children