Clinical trial NCT01541046: Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic
Official title: Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colic
Keywords: pediatric
infantile colic
probiotic treatment
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy term infant 21-90 days of age
2. Birth weight ≥2500 g
3. Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
4. With colic symptoms (\>3 hours of crying on \>3 days per week) with debut 10 ± 5 days before enrollment
5. Gestational age between 37 and 42 weeks
6. Apgar score higher than 7 at 5 minutes
7. Written informed consent from a parent

Exclusion Criteria:

1. Any chronic illness or gastrointestinal disorder as judged by the pediatrician
2. Any history of antibiotic treatment or probiotic supplementation
3. Failure to obtain a written consent by parent/legal guardian
4. Participation in other clinical trials
5. Infants with acute illness
6. Subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo

Primary outcomes:
measure: Mean change in crying time
timeFrame: Baseline, 7 days, 14 days, 21 days
Secondary outcomes:
measure: Number of responders vs. non-responders
timeFrame: Baseline, at 7, 14 and 21 days
measure: Parental quality of life
timeFrame: Daily for 21 days
measure: Number of episodes of crying
timeFrame: Over 21 days
measure: Duration of episodes of crying
timeFrame: Over 21 days
measure: Changes in stool consistency
timeFrame: Over 21 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Gideon Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chau K, Lau E, Greenberg S, Jacobson S, Yazdani-Brojeni P, Verma N, Koren G. Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. J Pediatr. 2015 Jan;166(1):74-8. doi: 10.1016/j.jpeds.2014.09.020. Epub 2014 Oct 23.