Contact information
Type
Scientific
Primary contact
Dr Eduardo Salazar-Lindo
ORCID ID
Contact details
Av. El Polo 740 Of. C-410
Lima
033
Peru
+51 1 435 7800
edsalaza@ec-red.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute watery diarrhoea
Intervention
1. Oral rehydration
2. Feeding with age-appropiate infant's food
3. Randomised to receive a milk formula with or without Lactobacillus casei strain GG
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1991
Overall trial end date
01/06/1992
Reason abandoned
Eligibility
Participant inclusion criteria
Male infants aged 3 - 36 months brought for treatment of acute watery diarrhoea with mild-moderate dehydration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
179
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/1991
Recruitment end date
01/06/1992
Locations
Countries of recruitment
Peru
Trial participating centre
Av. El Polo 740 Of. C-410
Lima
033
Peru
Sponsor information
Organisation
Universidad Peruana Cayetano Heredia (Peru)
Sponsor details
Av. Honorio Delgado 430
Lima
031
Peru
postmaster@upch.edu.pe
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
The study was supported by a grant from Valio Ltd, Helsinki (Finland) to the Child Health Foundation, Columbia, Maryland (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15345099
Publication citations
-
Results
Salazar-Lindo E, Miranda-Langschwager P, Campos-Sanchez M, Chea-Woo E, Sack RB, Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: a randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048]., BMC Pediatr, 2004, 4, 18, doi: 10.1186/1471-2431-4-18.