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 |
| Protocol serial number | N/A |
| Sponsor | Universidad Peruana Cayetano Heredia (Peru) |
| Funder | The study was supported by a grant from Valio Ltd, Helsinki (Finland) to the Child Health Foundation, Columbia, Maryland (USA) |
- 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
Scientific
Av. El Polo 740 Of. C-410
Lima
033
Peru
| Phone | +51 1 435 7800 |
|---|---|
| edsalaza@ec-red.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/1992 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 179 |
| Key inclusion criteria | Male infants aged 3 - 36 months brought for treatment of acute watery diarrhoea with mild-moderate dehydration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/1991 |
| Date of final enrolment | 01/06/1992 |
Locations
Countries of recruitment
- Peru
Study participating centre
Av. El Polo 740 Of. C-410
Lima
033
Peru
033
Peru
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
