Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhoea: a randomised, double-blind, placebo controlled clinical trial

ISRCTN ISRCTN67363048
DOI https://doi.org/10.1186/ISRCTN67363048
Secondary identifying numbers N/A
Submission date
30/08/2004
Registration date
31/08/2004
Last edited
07/08/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eduardo Salazar-Lindo
Scientific

Av. El Polo 740 Of. C-410
Lima
033
Peru

Phone +51 1 435 7800
Email edsalaza@ec-red.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcute watery diarrhoea
Intervention1. 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/1991
Completion date01/06/1992

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants179
Key inclusion criteriaMale infants aged 3 - 36 months brought for treatment of acute watery diarrhoea with mild-moderate dehydration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/1991
Date of final enrolment01/06/1992

Locations

Countries of recruitment

  • Peru

Study participating centre

Av. El Polo 740 Of. C-410
Lima
033
Peru

Sponsor information

Universidad Peruana Cayetano Heredia (Peru)
University/education

Av. Honorio Delgado 430
Lima
031
Peru

Email postmaster@upch.edu.pe
ROR logo "ROR" https://ror.org/03yczjf25

Funders

Funder type

Industry

The study was supported by a grant from Valio Ltd, Helsinki (Finland) to the Child Health Foundation, Columbia, Maryland (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 02/09/2004 Yes No