Completed

NCT Number: NCT01235884

Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

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

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Key information

Conditions

Minor Digestive Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bari, Bari, BA, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus reuteri

Dietary Supplement

1000000000 CFU per day (5 drops) for 28 days

Placebo

Dietary Supplement

5 drops daily for 28 days

Primary outcomes

Reduction of the onset of gaseous colic, regurgitation and of constipation.

Time frame: one year
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

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Nov 8, 2010
Registry last updated: Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed