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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01541046
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colic Biological: Biogaia L. reuteri DSM 17938 Biological: Probiotic Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial
Study Start Date : November 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of responders vs. non-responders [ Time Frame: Baseline, at 7, 14 and 21 days ]
    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.

  2. Parental quality of life [ Time Frame: Daily for 21 days ]
    Parental quality of life assessed by self-administered numerical rating scale from 0 (worst possible) to 10 (perfect well-being)

  3. Number of episodes of crying [ Time Frame: Over 21 days ]
    Reduction in the number of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo

  4. Duration of episodes of crying [ Time Frame: Over 21 days ]
    Reduction in the duration of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo

  5. Changes in stool consistency [ Time Frame: Over 21 days ]

Eligibility Criteria
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Ages Eligible for Study:   21 Days to 180 Days   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541046


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5V1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Gideon Koren, MD The Hospital for Sick Children
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gideon Koren, Director of MotherRisk Program, Clinical Pharmacology and Toxicology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01541046    
Other Study ID Numbers: 1000018504
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014
Keywords provided by Gideon Koren, The Hospital for Sick Children:
pediatric
infantile colic
probiotic treatment
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases