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

Colic Clinical Trial

Official title:

Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic: A Randomized Double-blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541046
• Other study ID #: 1000018504
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2012
• Last updated: November 19, 2014
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 180 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic

Intervention

Biological:
• Biogaia L. reuteri DSM 17938
Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™
• Probiotic Placebo
Description of Placebo: contains same excipients as Active Agent, without the active ingredient

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in crying time	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	Baseline, 7 days, 14 days, 21 days	No
Secondary	Number of responders vs. non-responders	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.	Baseline, at 7, 14 and 21 days	No
Secondary	Parental quality of life	Parental quality of life assessed by self-administered numerical rating scale from 0 (worst possible) to 10 (perfect well-being)	Daily for 21 days	No
Secondary	Number of episodes of crying	Reduction in the number of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo	Over 21 days	No
Secondary	Duration of episodes of crying	Reduction in the duration of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo	Over 21 days	No
Secondary	Changes in stool consistency		Over 21 days	No

External Links

•   Probiotics for Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial Investigating Lactobacillus reuteri DSM 17938