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

Phase 2

Completed

• Conditions: Colic
• Interventions: Biological: Biogaia L. reuteri DSM 17938; Biological: Probiotic Placebo

• Registration Number: NCT01541046
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biogaia L. reuteri DSM 17938	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.
Probiotic Placebo	Probiotic Placebo	Placebo drops (sunflower oil, medium chain triglyceride oil, silicon chloride), 5 drops, once a day for 21 days.

Primary Outcome Measures

Name	Time	Method
Mean change in crying time	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

Name	Time	Method
Number of responders vs. non-responders	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.
Number of episodes of crying	Over 21 days	Reduction in the number of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo
Parental quality of life	Daily for 21 days	Parental quality of life assessed by self-administered numerical rating scale from 0 (worst possible) to 10 (perfect well-being)
Changes in stool consistency	Over 21 days
Duration of episodes of crying	Over 21 days	Reduction in the duration of episodes of crying (measured with parental diary) with L. reuteri DSM 17938 versus placebo

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada