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

NCT03334604 | Completed

• 1 other identifier: AAD2017
• Study Type: interventional
• Target: 350
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Antibiotic-associated Diarrhea

Keywords

antibiotic-associated diarrhea; probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of antibiotic-associated diarrhea - alternative definition 1

  Up to 7th day after antibiotic cessation.

• Incidence of antibiotic-associated diarrhea - alternative definition 2

  Up to 7th day after antibiotic cessation.

• Incidence of diarrhea

  Up to 7th day after antibiotic cessation.

• Clostridium difficile-associated diarrhea

  Up to 7th day after antibiotic cessation.

• Duration of diarrhea

  Up to 7th day after antibiotic cessation.

Study Arms (2)

Multispecies probiotic group

EXPERIMENTAL

175 participants.

Dietary Supplement: Multispecies probiotic

Control group

PLACEBO COMPARATOR

175 participants.

Other: Placebo

Interventions

Multispecies probiotic DIETARY_SUPPLEMENT

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.

Multispecies probiotic group

Placebo OTHER

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

Control group

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Winclove Probiotics B.V.: collaborator

Study Sites (6)

OLVG location West

Amsterdam, 1061, Netherlands

Location

Amsterdam UMC, location VUmc

Amsterdam, 1081 HV, Netherlands

Location

OLVG location East

Amsterdam, 1092, Netherlands

Location

Amsterdam UMC, location AMC

Amsterdam, 1105, Netherlands

Location

Department of Paediatrics, St. Hedwig of Silesia Hospital

Trzebnica, Silesian Voivodeship, 55-100, Poland

Location

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, 02-091, Poland

Location

Related Publications (3)

• Dierikx TH, Malinowska AM, Lukasik J, Besseling-van der Vaart I, Belzer C, Szajewska H, de Meij TGJ; Multispecies Probiotic in AAD Study Group. Probiotics and Antibiotic-Induced Microbial Aberrations in Children: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2418129. doi: 10.1001/jamanetworkopen.2024.18129.

  PMID: 38967929 DERIVED

• Lukasik J, Dierikx T, Besseling-van der Vaart I, de Meij T, Szajewska H; Multispecies Probiotic in AAD Study Group. Multispecies Probiotic for the Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial. JAMA Pediatr. 2022 Sep 1;176(9):860-866. doi: 10.1001/jamapediatrics.2022.1973.

  PMID: 35727573 DERIVED

• Lukasik J, Szajewska H. Effect of a multispecies probiotic on reducing the incidence of antibiotic-associated diarrhoea in children: a protocol for a randomised controlled trial. BMJ Open. 2018 Jun 4;8(5):e021214. doi: 10.1136/bmjopen-2017-021214.

  PMID: 29866789 DERIVED

Study Officials

• Jan Łukasik, MD

  Department of Paediatrics, The Medical University of Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 7, 2017
• Study Start: February 16, 2018
• Primary Completion: May 13, 2021
• Study Completion: May 13, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (4); PL (2)