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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01541046
First received: February 23, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Colic
Biological: Biogaia L. reuteri DSM 17938
Biological: Probiotic Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Mean change in crying time [ Time Frame: Baseline, 7 days, 14 days, 21 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of responders vs. non-responders [ Time Frame: Baseline, at 7, 14 and 21 days ] [ Designated as safety issue: No ]
    Number of responders versus non-responders with L. reuteri versus placebo at the time points 7, 14, and 21 days. Responder is defined as a decrease in daily average crying time of 50% during the study as measured using the maternal daily diary.

  • Parental quality of life [ Time Frame: Daily for 21 days ] [ Designated as safety issue: No ]
    Parental quality of life assessed by self-administered numerical rating scale from 0 (worst possible) to 10 (perfect well-being)

  • Number of episodes of crying [ Time Frame: Over 21 days ] [ Designated as safety issue: No ]
    Reduction in the number of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo

  • Duration of episodes of crying [ Time Frame: Over 21 days ] [ Designated as safety issue: No ]
    Reduction in the duration of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo

  • Changes in stool consistency [ Time Frame: Over 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: Biogaia L. reuteri DSM 17938
Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™
Placebo Comparator: Probiotic Placebo
Placebo drops (sunflower oil, medium chain triglyceride oil, silicon chloride), 5 drops, once a day for 21 days.
Biological: Probiotic Placebo
Description of Placebo: contains same excipients as Active Agent, without the active ingredient

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

Ages Eligible for Study:   up to 180 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541046

Contacts
Contact: Gideon Koren, MD 416-813-5778 gideon.koren@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5V1X8
Contact: Kim Chau, MSc    416-813-7283    kim.chau@sickkids.ca   
Principal Investigator: Gideon Koren, MD         
Sub-Investigator: Kim Chau, MSc         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Gideon Koren, Director of MotherRisk Program, Clinical Pharmacology and Toxicology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01541046     History of Changes
Other Study ID Numbers: 1000018504
Study First Received: February 23, 2012
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatric
infantile colic
probiotic treatment

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on July 20, 2014