Probiotics for the prevention of antibiotic-associated diarrhoea and Clostridium difficile associated diarrhoea

ISRCTN ISRCTN19604441
DOI https://doi.org/10.1186/ISRCTN19604441
ClinicalTrials.gov (NCT) NCT00973908
Clinical Trials Information System (CTIS) 2008-005244-16
Protocol serial number 8157
Sponsor Wrightington, Wigan and Leigh NHS Foundation Trust (UK)
Funder Ferring Pharmaceuticals Ltd (UK)
Submission date
21/10/2010
Registration date
21/10/2010
Last edited
01/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christian Selinger
Scientific

Wrightington, Wigan and Leigh NHS Foundation Trust
Endoscopy Unit
Wigan Lane
Wigan
WN1 2NN
United Kingdom

christian.selinger@web.de

Study information

Primary study designInterventional
Study designMulticentre randomised interventional phase II prevention trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleProbiotics for the prevention of antibiotic associated diarrhoea and Clostridium difficile associated diarrhoea: a multicentre randomised interventional phase II prevention trial
Study objectivesThe study aims to establish whether VSL#3 compared to placebo prevents antibiotic-associated diarrhoea and Clostridium difficile associated diarrhoea in hospitalised patients on systemic antibiotics.
Ethics approval(s)North Staffordshire Local Research Ethics Committee 3 approved on the 22nd April 2010 (ref: 08/H1201/147)
Health condition(s) or problem(s) studiedTopic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal
InterventionIntervention: 1 sachet of VSL#3 twice daily for the duration of the antibiotic course and seven days thereafter.
Control: 1 sachet of placebo twice daily for the duration of the antibiotic cource and seven days thereafter.

Follow-up until 28 days after the last antibiotic dose.
Study entry: single randomisation only
Intervention typeDrug
PhasePhase II
Drug / device / biological / vaccine name(s)VSL#3
Primary outcome measure(s)

Development of CDAD, measured at 28 days after last antibiotic dose

Key secondary outcome measure(s)

1. 30 day mortality
2. Development of AAD, measured at 28 days post-last antibiotic dose
3. Length of hospital stay

Completion date10/03/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration445
Key inclusion criteria1. Systemic antibiotics
2. Aged 18 years or older, either sex
3. Able to take enteral medication (sachets)
Key exclusion criteria1. Diarrhoea at screening
2. Unable to take enteral medication
3. Patients on intensive care units
4. Severe immunosuppression (neutropenia, acquired immunodeficiency syndrome [AIDS], congenital immunoparesis, chemotherapy)
5. Risk of endocarditis (artificial heart valves, history of rheumatic heart disease or infective endocarditis)
6. Regular consumption of probiotics until 1 week prior to admission
7. Acute severe pancreatitis
8. Persistent vomiting (two days or more)
Date of first enrolment01/04/2010
Date of final enrolment10/03/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan
WN1 2NN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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