Colic | Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic
Colic research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
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.
Biological:Biogaia L. reuteri DSM 17938Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™
Biological:Probiotic PlaceboDescription of Placebo: contains same excipients as Active Agent, without the active ingredient
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.
Biogaia L. reuteri DSM 17938Biogaia L. reuteri DSM 17938, probiotic infant drops (5 drops=10^8 cfu),5 drops, once per day for 21 days.
Probiotic PlaceboPlacebo drops (sunflower oil, medium chain triglyceride oil, silicon chloride), 5 drops, once a day for 21 days.
Start Date: November 2011
Completed Date: June 2014
Phase: Phase 2
Primary Outcome: Mean change in crying time
Secondary Outcome: Number of responders vs. non-responders
Study sponsors, principal investigator, and references
Principal Investigator: Gideon Koren, MD
Lead Sponsor: The Hospital for Sick Children