Probiotics in acute gastroenteritis
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.
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).
Multicentre, single-blind, controlled trial
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
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 cows 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.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
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.
Target number of participants
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)
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
Recruitment end date
Countries of recruitment
Trial participating centre
via Pansini 5
The research was sponsored by the Department of Pediatrics of the University of Naples Federico II (Italy)
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)
Canani RB, Cirillo P, Terrin G, Cesarano L, Spagnuolo MI, De Vincenzo A, Albano F, Passariello A, De Marco G, Manguso F, Guarino A, Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations., BMJ, 2007, 335, 7615, 340, doi: 10.1136/bmj.39272.581736.55.