Antibiotic-associated DiarrheaNCT03334604
The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.
A study testing Multispecies probiotic in people with Antibiotic-associated Diarrhea, run by Medical University of Warsaw at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Multispecies probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 16 Feb 2018to 13 May 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Netherlands4 sites
OLVG location West
Amsterdam, 1061
Amsterdam UMC, location VUmc
Amsterdam, 1081 HV
OLVG location East
Amsterdam, 1092
Amsterdam UMC, location AMC
Amsterdam, 1105
Poland2 sites
Department of Paediatrics, St. Hedwig of Silesia Hospital
Trzebnica, Silesian Voivodeship, 55-100
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, 02-091
About this study
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.
Read the 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 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.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- Multispecies probiotic, Placebo
- Keywords
- antibiotic-associated diarrhea, probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispecies probioticDietary 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.
PlaceboOther
Placebo identical in taste, smell and color to the multispecies probiotic.
| Study group | Role | What they receive |
|---|---|---|
| Multispecies probiotic group | Experimental | 175 participants. Receives: Dietary Supplement: Multispecies probiotic |
| Control group | Placebo comparator | 175 participants. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7th day after antibiotic cessation.
Secondary outcomes (9)
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.
Measured: Up to 7th day after antibiotic cessation.
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.
Measured: Up to 7th day after antibiotic cessation.
Incidence of diarrhea
≥3 loose or watery stools per day for a minimum of 24 hours regardless of its aetiology.
Measured: Up to 7th day after antibiotic cessation.
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.
Measured: Up to 7th day after antibiotic cessation.
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.
Measured: Up to 7th day after antibiotic cessation.
Discontinuation of the antibiotic treatment due to severity of diarrhoea
Measured: Up to 7th day after antibiotic cessation.
Hospitalisation caused by diarrhoea
Measured: Up to 7th day after antibiotic cessation.
Need for intravenous rehydration
Measured: Up to 7th day after antibiotic cessation.
Adverse events
Measured: Up to 7th day after antibiotic cessation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start16 Feb 2018
- Primary completion13 May 2021
- Study completion13 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Winclove Probiotics B.V.
- Responsible party
- Sponsor
- Investigators
- Jan Łukasik, MD, Principal investigator, Department of Paediatrics, The Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334604
- Sponsor's protocol ID
- AAD2017
- Status last verified
- Jan 2021
- First submitted
- 24 Oct 2017
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected in the course of this study are available from the Principal Investigator upon reasonable request.
Publications
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.
PubMed 38967929Lukasik 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.
PubMed 35727573Lukasik 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.
PubMed 29866789