The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.

Antibiotic-associated Diarrhea Clinical Trial

Official title:

The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334604
• Other study ID #: AAD2017
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: May 13, 2021

Study information

• Verified date: January 2021
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this trial, the investigators aim to assess the effectiveness of a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24) in reducing the risk of antibiotic-associated diarrhoea in a group of children undergoing antibiotic therapy for common infections.

Description:

Certain individual probiotic strains have been proven to be effective in reducing the risk of antibiotic-associated diarrhoea (AAD). However, the effects of using multispecies probiotics remain unclear. The investigators aim to assess the effectiveness of a specific multispecies probiotic preparation (Ecologic AAD Kids) in reducing the incidence of AAD in children.

In this trial, a total of 350 children aged 3 months to 18 years, undergoing antibiotic treatment, will be randomly allocated to receive either a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24) at a total dose of 10^10 colony-forming units daily, or a placebo, from the first day of antibiotic treatment until 7 days after antibiotic cessation. The primary outcome measure will be the incidence of AAD, defined as ≥3 loose or watery stools (a score of A on the Amsterdam Infant Stool Scale for children younger than 1 year and a score of 5-7 on the Bristol Stool Form scale for children older than 1 year) in 24 hours, caused either by Clostridium difficile or of otherwise unexplained aetiology (after testing for common diarrhoeal pathogens), occurring during and/or up to 7 days after the end of the antibiotic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 13, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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 antibiotic intake, receiving 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.

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• Multispecies probiotic
Multispecies probiotic consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 and Lactobacillus salivarius W24 at a dose of 5x10^9 Colony Forming Units (CFU), twice daily, orally.

Other:
• Placebo
Placebo identical in taste, smell and color to the multispecies probiotic.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam
Netherlands	Amsterdam UMC, location VUmc	Amsterdam
Netherlands	OLVG location East	Amsterdam
Netherlands	OLVG location West	Amsterdam
Poland	Department of Paediatrics, St. Hedwig of Silesia Hospital	Trzebnica	Silesia
Poland	Department of Paediatrics, The Medical University of Warsaw, Poland	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Winclove Probiotics B.V.

Countries where clinical trial is conducted

Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of antibiotic-associated diarrhea	Antibiotic-associated diarrhea will be defined as 3 or more loose or watery stools (a score of A on the Amsterdam Infant Stool Scale or 5-7 on the Bristol Stool Form scale) per day in a 24-hour period, caused by C. difficile infection or of otherwise unexplained aetiology after testing for common diarrhoeal pathogens (rotavirus, adenovirus, norovirus, Campylobacter spp., Salmonella spp., Shigella spp., and Yersinia spp.), occurring during the intervention period.	Up to 7th day after antibiotic cessation.
Secondary	Incidence of antibiotic-associated diarrhea - alternative definition 1	=3 loose or watery stools per day for a minimum of a 48-hour period caused by C. difficile infection or of otherwise unexplained aetiology.	Up to 7th day after antibiotic cessation.
Secondary	Incidence of antibiotic-associated diarrhea - alternative definition 2	=2 loose or watery stools per day for a minimum of a 24-hour period caused by C. difficile infection or of otherwise unexplained aetiology.	Up to 7th day after antibiotic cessation.
Secondary	Incidence of diarrhea	=3 loose or watery stools per day for a minimum of 24 hours regardless of its aetiology.	Up to 7th day after antibiotic cessation.
Secondary	Clostridium difficile-associated diarrhea	=3 loose or watery stools per day for a minimum of 24 hours caused by C. difficile confirmed by the presence of toxin-producing C. difficile in stools.	Up to 7th day after antibiotic cessation.
Secondary	Duration of diarrhea	Defined as the time until the normalisation of stool consistency according to the Bristol Stoo Form (BSF) or Amsterdam Infant Stool Scale (AISS) - on BSF numbers 1, 2, 3 and 4; on AISS scale, letters B or C, and the presence of normal stools for 48 h.	Up to 7th day after antibiotic cessation.
Secondary	Discontinuation of the antibiotic treatment due to severity of diarrhoea		Up to 7th day after antibiotic cessation.
Secondary	Hospitalisation caused by diarrhoea		Up to 7th day after antibiotic cessation.
Secondary	Need for intravenous rehydration		Up to 7th day after antibiotic cessation.
Secondary	Adverse events		Up to 7th day after antibiotic cessation.