Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

University of Bari

Status: Completed

Conditions: Minor Digestive Disorders

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus reuteri

Study type: Interventional

Funder types: Other

Identifiers

NCT01235884

FI-RF-01/10

Details and patient eligibility

About

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

Enrollment: 492 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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492 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri

Active Comparator group

Description:

Dietary Supplement

Treatment:

Dietary Supplement: Lactobacillus reuteri

Placebo

Placebo Comparator group

Description:

Dietary Supplement

Treatment:

Dietary Supplement: Placebo