Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic

NCT ID: NCT01541046

Last Updated: 2014-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Biogaia L. reuteri DSM 17938

Biogaia L. reuteri DSM 17938, probiotic infant drops (5 drops=10\^8 cfu),5 drops, once per day for 21 days.

Group Type: EXPERIMENTAL

Biogaia L. reuteri DSM 17938

Intervention Type: BIOLOGICAL

Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™

Probiotic Placebo

Placebo drops (sunflower oil, medium chain triglyceride oil, silicon chloride), 5 drops, once a day for 21 days.

Group Type: PLACEBO_COMPARATOR

Probiotic Placebo

Intervention Type: BIOLOGICAL

Description of Placebo: contains same excipients as Active Agent, without the active ingredient

Interventions

Biogaia L. reuteri DSM 17938

Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™

Intervention Type: BIOLOGICAL

Probiotic Placebo

Description of Placebo: contains same excipients as Active Agent, without the active ingredient

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 21 Days
• Maximum Eligible Age: 180 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Gideon Koren

Director of MotherRisk Program, Clinical Pharmacology and Toxicology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gideon Koren, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25444531 (View on PubMed)

Other Identifiers

1000018504

Identifier Type: -

Identifier Source: org_study_id