NCT01235884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

November 5, 2010

Last Update Submit

February 4, 2013

Conditions

Minor Digestive Disorders

Keywords

gaseous colic, regurgitation and of constipation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lactobacillus reuteri

ACTIVE COMPARATOR

Dietary Supplement

Dietary Supplement: Lactobacillus reuteri

Placebo

PLACEBO COMPARATOR

Dietary Supplement

Dietary Supplement: Placebo

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

1000000000 CFU per day (5 drops) for 28 days

Lactobacillus reuteri
PlaceboDIETARY_SUPPLEMENT

5 drops daily for 28 days

Placebo

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • neonates of 37-42 week gestational age and appropriate birth weight
  • Recruitment age: until 7 days of life
  • Informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Bari

Bari, BA, 70124, Italy

Location

Ospedale Sant'Orsola Malpighi

Bologna, BO, Italy

Location

Arcispedale S. Anna

Ferrara, FE, Italy

Location

Ospedale Civile

Crotone, KR, Italy

Location

Ospedale di Sesto S. Giovanni

Milan, MI, Italy

Location

Ospedale "SS. Annunziata"

Taranto, TA, Italy

Location

Ospedale "Frà Castoro"

San Bonifacio, VR, Italy

Location

Policlinico "S. Matteo"

Pavia, Italy

Location

Related Publications (1)

  • Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.

    PMID: 24424513DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Flavia Indrio, MD

    University of Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Neonatologist Pediatric Gastroenterologist

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 8, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2011

Study Completion

July 1, 2012

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

IT(8)