Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.

Detailed Description
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NOTE: The study never started.

Official Title
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The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic

Conditions
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Infantile Colic

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exclusively breastfed Infants Infant aged of 29 days to 3 months With a diagnosis of infantile colic as defined by the Rome III criteria Birth at term and eutrophic (weight, height, head circumference) Apgar score> 7 at 5 minutes Consent to the study signed by the two parents. Availability during the study period Exclusion Criteria: Associated severe chronic disease Acute infectious disease Personal or family first degree history of allergy to milk proteins Several infants of the same family from a multiple pregnancy Infants who received antibiotics one week prior to randomization Infants who received probiotics one week prior to randomization Mother who received antibiotics 1 week before randomization Regular consumption of probiotics by the mother 1 week before randomization Infants-included in another clinical study Lack of insurance coverage by the french social security Non exclusively breastfed infants

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus reteuri<br>Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days | Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic<br>* Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion.<br>|
| Placebo Comparator: Placebo<br>Other: Placebo | Other: Placebo<br>* Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes. |  | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The responders rates at D14 and D21 in the probiotic group compared to the placebo group. |  | Day 14 and day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Gastroenterology, Probiotics, Lactobacillus reuteri