The Influence of Probiotics on the incidence of pediatric Antibiotic-associated Diarrhoea * IPAD study

Phase 3

Completed

Conditions: antibiotic-associated diarrhea
diarrhoea
10017947

Registration Number: NL-OMON49721

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 175

Inclusion Criteria

Children receiving oral or intravenous antibiotics for common infections,
willing and able to start the probiotic intervention within 24 hours after the
start of the broad-spectrum antibiotics (broad-spectrum penicillins,
cephalosporins, fluoroquinolones, clindamycin).

Exclusion Criteria

Prior use of antibiotics within the previous 4 weeks, presence of a severe or
generalised infection, history of severe chronic disease (e.g., cancer,
inflammatory bowel disease, tuberculosis), critical/life-threatening illness,
immunodeficiency, history of pre-existing diarrhoea within the previous 4
weeks, exclusive breastfeeding, allergy or hypersensitivity to any component of
the study product, tube-feeding, use of proton-pump inhibitors, laxatives or
anti-diarrhoeal drugs, as well as use of a probiotic product containing L
rhamnosus GG or S boulardii 14 days before and during the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1.Incidence of antibiotic-associated diarrhea [ Time Frame: Up to 7th day after<br /><br>antibiotic cessation. ]<br /><br>Antibiotic-associated diarrhea will be defined as 3 or more loose or watery<br /><br>stools (a score of A on the Amsterdam Infant Stool Scale or 5-7 on the Bristol<br /><br>Stool Form scale) per day in a 24-hour period, caused by C. difficile infection<br /><br>or of otherwise unexplained aetiology after testing for common diarrhoeal<br /><br>pathogens (rotavirus, adenovirus, norovirus, Campylobacter spp., Salmonella<br /><br>spp., Shigella spp., and Yersinia spp.), occurring during the intervention<br /><br>period.</p><br>

Secondary Outcome Measures