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Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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 |
- 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
- 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.
- 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)
- 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
- 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
- Changes in stool consistency [ Time Frame: Over 21 days ]
| Enrollment: | 55 |
| Study Start Date: | November 2011 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 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 (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Healthy term infant 21-90 days of age
- Birth weight ≥2500 g
- Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
- With colic symptoms (>3 hours of crying on >3 days per week) with debut 10 ± 5 days before enrollment
- Gestational age between 37 and 42 weeks
- Apgar score higher than 7 at 5 minutes
- Written informed consent from a parent
Exclusion Criteria:
- Any chronic illness or gastrointestinal disorder as judged by the pediatrician
- Any history of antibiotic treatment or probiotic supplementation
- Failure to obtain a written consent by parent/legal guardian
- Participation in other clinical trials
- Infants with acute illness
- Subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01541046
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5V1X8 | |
| Principal Investigator: | Gideon Koren, MD | The Hospital for Sick Children |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | November 19, 2014 |
Keywords provided by Gideon Koren, The Hospital for Sick Children:
|
pediatric infantile colic probiotic treatment |
Additional relevant MeSH terms:
|
Colic Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on July 14, 2017