Condition category
Digestive System
Date applied
01/03/2007
Date assigned
27/04/2007
Last edited
13/08/2007
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

Prof Alfredo Guarino

ORCID ID

Contact details

via Pansini 5
Naples
80131
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00081877

Study information

Scientific title

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

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).

Study design

Multicentre, single-blind, controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute gastroenteritis

Intervention

All enrolled children were rehydrated orally with 60 mMol Na+ Oral Rehydration Solution (ORS) for 3–6 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

Phase

Not Specified

Drug names

Oral Rehydration Solution

Primary outcome measures

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

01/10/1999

Overall trial end date

30/09/2000

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

540

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

Trial participating centre

via Pansini 5
Naples
80131
Italy

Sponsor information

Organisation

Department of Pediatrics, University of Naples Federico II (Italy)

Sponsor details

via Pansini 5
Naples
80131
Italy

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The research was sponsored by the Department of Pediatrics of the University of Naples Federico II (Italy)

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/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17690340

Publication citations

  1. Results

    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.

Additional files

Editorial Notes