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

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ClinicalTrials.gov Identifier: NCT03334604
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Winclove Probiotics B.V.
Information provided by (Responsible Party):
Medical University of Warsaw

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.

Condition or disease Intervention/treatment Phase
Antibiotic-associated Diarrhea Dietary Supplement: Multispecies probiotic Other: Placebo Not Applicable

Detailed 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 6 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
Experimental: Multispecies probiotic group
175 participants.
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.

Placebo Comparator: Control group
175 participants.
Other: Placebo
Placebo identical in taste, smell and color to the multispecies probiotic.




Primary Outcome Measures :
  1. Incidence of antibiotic-associated diarrhea [ Time Frame: Up to 7th day after antibiotic cessation. ]
    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.


Secondary Outcome Measures :
  1. Incidence of antibiotic-associated diarrhea - alternative definition 1 [ Time Frame: Up to 7th day after antibiotic cessation. ]
    ≥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.

  2. Incidence of antibiotic-associated diarrhea - alternative definition 2 [ Time Frame: Up to 7th day after antibiotic cessation. ]
    ≥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.

  3. Incidence of diarrhea [ Time Frame: Up to 7th day after antibiotic cessation. ]
    ≥3 loose or watery stools per day for a minimum of 24 hours regardless of its aetiology.

  4. Clostridium difficile-associated diarrhea [ Time Frame: Up to 7th day after antibiotic cessation. ]
    ≥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.

  5. Duration of diarrhea [ Time Frame: Up to 7th day after antibiotic cessation. ]
    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.

  6. Discontinuation of the antibiotic treatment due to severity of diarrhoea [ Time Frame: Up to 7th day after antibiotic cessation. ]
  7. Hospitalisation caused by diarrhoea [ Time Frame: Up to 7th day after antibiotic cessation. ]
  8. Need for intravenous rehydration [ Time Frame: Up to 7th day after antibiotic cessation. ]
  9. Adverse events [ Time Frame: Up to 7th day after antibiotic cessation. ]


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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334604


Contacts
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Contact: Jan Łukasik, MD +48 22 317 9421 jan.m.lukasik@gmail.com
Contact: Hanna Szajewska, MD, PhD +48 22 317 9421 hania@ipgate.com

Locations
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Poland
Department of Paediatrics, The Medical University of Warsaw, Poland Recruiting
Warsaw, Poland, 02-091
Contact: Jan Łukasik, MD    0048223179535    jan.m.lukasik@gmail.com   
Principal Investigator: Jan Łukasik, MD         
Sponsors and Collaborators
Medical University of Warsaw
Winclove Probiotics B.V.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03334604     History of Changes
Other Study ID Numbers: AAD2017
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:
antibiotic-associated diarrhea
probiotics

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents