NCT00273949

Brief Summary

The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to prevent hospital acquired infection in children

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 6, 2008

Status Verified

September 1, 2005

First QC Date

January 9, 2006

Last Update Submit

February 5, 2008

Conditions

Nosocomial Infection

Keywords

LactulosePrebioticsNosocomial infectionchildreninfants

Outcome Measures

Primary Outcomes (1)

  • The incidence of diarrhea

Secondary Outcomes (1)

  • Incidence of rotavirus diarrhea

Interventions

lactuloseDRUG

Eligibility Criteria

Age2 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All children aged 2 to 36 months who are admitted to the hospital for reasons other than diarrhea will be eligible for the study.

You may not qualify if:

  • Children with a history of probiotics or prebiotics use within 7 days before admission, acute gastroenteritis within 3 days before admission, vomiting, treated chronic constipation, known anatomic problem in the gastrointestinal tract will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Department, Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Related Publications (3)

  • Mastretta E, Longo P, Laccisaglia A, Balbo L, Russo R, Mazzaccara A, Gianino P. Effect of Lactobacillus GG and breast-feeding in the prevention of rotavirus nosocomial infection. J Pediatr Gastroenterol Nutr. 2002 Oct;35(4):527-31. doi: 10.1097/00005176-200210000-00013.

    PMID: 12394379BACKGROUND

  • Szajewska H, Kotowska M, Mrukowicz JZ, Armanska M, Mikolajczyk W. Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants. J Pediatr. 2001 Mar;138(3):361-5. doi: 10.1067/mpd.2001.111321.

    PMID: 11241043BACKGROUND

  • Schumann C. Medical, nutritional and technological properties of lactulose. An update. Eur J Nutr. 2002 Nov;41 Suppl 1:I17-25. doi: 10.1007/s00394-002-1103-6.

    PMID: 12420112BACKGROUND

MeSH Terms

Conditions

Cross Infection

Interventions

Lactulose

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Ron Shaoul

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

January 1, 2006

Study Completion

January 1, 2007

Last Updated

February 6, 2008

Record last verified: 2005-09

Locations

IL(1)