Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

Study Overview
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Brief Summary
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Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation. Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days. After the inclusion, at baseline will be performed : Paediatric visit antropometric valutation number of the daily crying minutes, number of regurgitation and number of daily evacuation The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses: Paediatric visit antropometric valutation number of daily crying minutes numbers of regurgitation numbers of evacuations Primary outcome : To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic, regurgitation and of constipation. Inclusion criteria neonates of 37-42 week gestational age and appropriate birth weight Recruitment age: until 7 days of life Informed consent signed Exclusion criteria Presence of other gastrointestinal diseases. Use of FANS, aspirin or other drugs Use of antibiotics and/or PPIs e/o anti-H2 Participation to other clinical trials

Official Title
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Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.

Conditions
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Minor Digestive Disorders

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neonates of 37-42 week gestational age and appropriate birth weight Recruitment age: until 7 days of life Informed consent signed Exclusion Criteria: Presence of other gastrointestinal diseases. Use of FANS, aspirin or other drugs Use of antibiotics and/or PPIs e/o anti-H2 Participation to other clinical trials

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus reuteri<br>Dietary Supplement | Dietary Supplement: Lactobacillus reuteri<br>* 1000000000 CFU per day (5 drops) for 28 days<br>|
| Placebo Comparator: Placebo<br>Dietary Supplement | Dietary Supplement: Placebo<br>* 5 drops daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the onset of gaseous colic, regurgitation and of constipation. | After the inclusion, at baseline will be performed : Paediatric visit antropometric valutation number of the daily crying minutes, number of regurgitation and number of daily evacuation The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses: Paediatric visit antropometric valutation number of daily crying minutes numbers of regurgitation numbers of evacuations | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gaseous colic, regurgitation and of constipation