Condition category
Digestive System
Date applied
30/08/2004
Date assigned
31/08/2004
Last edited
07/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes