Probiotics for the treatment of acute gastroenteritis: a randomised clinical trial with five different preparations
| ISRCTN | ISRCTN56067537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56067537 |
| Secondary identifying numbers | 00081877 |
- Submission date
- 01/03/2007
- Registration date
- 27/04/2007
- Last edited
- 06/10/2020
- 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
Not provided at time of registration
Contact information
Prof Alfredo Guarino
Scientific
Scientific
via Pansini 5
Naples
80131
Italy
Study information
| Study design | Multicentre, single-blind, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Probiotics for the treatment of acute gastroenteritis: a randomised clinical trial with five different preparations |
| Study acronym | Probiotics in acute gastroenteritis |
| Study hypothesis | Probiotics are increasingly used adjunctive to oral rehydration solution to treat childhood gastroenteritis. Numerous preparations are available, but clinical efficacy has not been proven for many of them. We aimed to comparatively investigate the efficacy of five probiotic preparations in the treatment of acute gastroenteritis in children. |
| Ethics approval(s) | The study protocol and consent form were approved by the Ethics Committee of the School of Medicine at the University of Naples Federico II on the 1st September 1999 (ref: 5407). |
| Condition | Acute gastroenteritis |
| Intervention | All enrolled children were rehydrated orally with 60 mMol Na+ Oral Rehydration Solution (ORS) for 36 hours and then re-fed with full strength, lactose-containing formula or cow's milk, depending on age. In addition to the above supportive treatment, children were randomized to the following groups: 1. Oral rehydration solution alone (control group) containing Na+ 60 mEq/L, K+ 20 mEq/L, Glucose 16.7 g/L 2. Lactobacillus casei strain rhamnosus GG (Lactobacillus GG; 6 x 10^9 CFU/dose, bid) 3. Saccharomyces boulardii (5 x 10^9 live micro-organisms/dose, bid) 4. Bacillus clausii (10^9 CFU/dose, bid) 5. Mix of Lactobacillus delbrueckii var. bulgaricus + Streptococcus thermophilus + Lactobacillus acidophilus + Bifidobacterium bifidum (10^9 CFU + 10^9 CFU + 10^9 CFU + 5 x 10^8 CFU/dose, bid) 6. Enterococcus faecium strain SF68 (7.5 x 10^7 CFU/dose, bid). Probiotic preparations were prescribed for 5 days and administered by the oral route suspended in 20 ml of water according to the manufacturers' indications. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral Rehydration Solution |
| Primary outcome measure | Diarrhoea duration defined as the time in hours from the first to the last abnormal (loose or liquid) stools preceding a normal stool output. |
| Secondary outcome measures | 1. Duration of vomiting and fever, defined by the time in days from the first to the last episode of vomiting and/or fever (boby temperature > 37.5°C) 2. Hospitalization investigated as hospital admissions rate |
| Overall study start date | 01/10/1999 |
| Overall study end date | 30/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 540 |
| Participant inclusion criteria | Children three to 36 months of age seen in paediatricians' offices because of diarrhoea were eligible for the study. Patients presenting diarrhoea lasting less than 48 hours with informed consent given from parents were included in the study. |
| Participant exclusion criteria | 1. Malnutrition as judged by body weight/height ratio 2. Clinical signs of severe dehydration 3. Clinical signs of a coexisting acute systemic illness (meningitis, sepsis, pneumonia) 4. Immunodeficiency 5. Underlying severe chronic diseases 6. Cystic fibrosis 7. Food allergy or other chronic gastrointestinal diseases 8. Use of probiotics in the previous 3 weeks 9. Use of antibiotics or any antidiarrhoeal medication in the previous 3 weeks and during study medication 10. Poor compliance (defined by administration of less than four doses of study medication) |
| Recruitment start date | 01/10/1999 |
| Recruitment end date | 30/09/2000 |
Locations
Countries of recruitment
- Italy
Study participating centre
via Pansini 5
Naples
80131
Italy
80131
Italy
Sponsor information
Department of Pediatrics, University of Naples Federico II (Italy)
University/education
University/education
via Pansini 5
Naples
80131
Italy
"ROR" |
https://ror.org/05290cv24 |
|---|
Funders
Funder type
Hospital/treatment centre
The research was sponsored by the Department of Pediatrics of the University of Naples Federico II (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 18/08/2007 | Yes | No |
Editorial Notes
06/10/2020: The following changes have been made:
1. The scientific title has been added.
2. The secondary study design has been changed from "Non randomised controlled trial" to "Randomised controlled trial"
