Plain English Summary
Background and study aims
Probiotics, defined as ‘live microorganisms which, when administered in adequate amounts, confer a health benefit on the host’, have been proposed to help maintain a healthy gut microbiota in hospitalised patients on antibiotic therapy, particularly those on broad spectrum antibiotics. It is hypothesised that maintenance of a healthy commensal microbiota during antibiotic treatment by taking a probiotic every day will significantly reduce the occurrence of antibiotic associated diarrhoea (AAD) and Clostridium difficile associated diarrhoea (CDAD), improving the quality of life in spinal cord injury patients over time. A previous trial in patients with spinal cord injuries (SCI) suggests that probiotics can prevent antibiotic associated diarrhoea (AAD). A number of studies have reported that Yakult (Lactobacillus casei Shirota) can help reduce antibiotic-associated diarrhoea. However, in order to confirm these effects find out how well Lactobacillus casei Shirota (LcS) works in these patients, a larger study including different geographical locations should be carried out.
Who can participate?
Adults (aged at least 18), likely to remain at the Spinal Cord Injury Centre (SCIC) for more than 6 weeks and have been taking antibiotics for at least 3 days.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given one bottle of Yakult containing 6.5x10/9 Lactobacillus casei Shirota once a day during the course of antibiotics and for 7 days after the course finishes. Those in group 2 are given a placebo. All participants are monitored for occurance of AAD and CDAD. Gastrointestinal microbiota are also measured and also an assessment of quality of life.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Stoke Mandeville Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2014 to October 2017
Who is funding the study?
Yakult Honsha Co., Ltd
Who is the main contact?
Mr Edmund Chiu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17618
Study information
Scientific title
Effect of Lactobacillus casei Shirota in preventing antibiotic associated diarrhoea (AAD) including Clostridium difficile associated diarrhoea (CDAD) in patients with spinal cord injuries: a multicentre, randomised, double-blind, placebo-controlled trial
Acronym
ECLISP
Study hypothesis
It is hypothesised that maintenance of a healthy commensal microbiota during antibiotic treatment by administration of a daily probiotic (Lactobacillus casei Shirota, as Yakult) will significantly reduce the occurrence of AAD and CDAD, and thus improve quality of life in spinal cord injury patients over time in comparison to the placebo control.
Ethics approval
Oxford REC, 25/09/2014, 14/SC/1101
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Antibiotic associated/Clostridium difficile diarrhoea
Intervention
Lactobacillus casei Shirota. One bottle of Yakult containing 6.5x10/9 Lactobacillus casei Shirota once a day during the course of antibiotics and for 7 days after the course finishes.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Occurrence of antibiotic-associated dairrhoea: Timepoint(s): 30 days
Secondary outcome measures
Analyse the effect of LcS on:
1. Occurrence of C. difficile diarrhoea
2. Duration of diarrhoea
3. Gastrointestinal microbiota
4. Quality of life
Measured 30 days after finishing probiotic/placebo.
Overall trial start date
12/11/2014
Overall trial end date
31/10/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult (≥18 years)
2. Patient is likely to remain in the Spinal Cord Injury Centre (SCIC) for more than 6 weeks can be included
3. Newly started antibiotics (for a minimum of 3 days) (single or multiple)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 360; UK Sample Size: 360
Participant exclusion criteria
1. Re-recruit patient (1st recruitment only)
2. Antibiotics for prophylaxis use
3. Diarrhoea prior to recruitment
4. Bowel pathology that could result in diarrhoea
5. Recent bowel surgery
6. Infective endocarditis
7. Active inflammatory bowel disease
8. Pancreatitis
9. Regular probiotic use
10. Antibiotic use in the 30 days prior to the study product first administration
11. Severe illness
12. Immunosuppression
13. Nil-by-mouth status for any reason
14. Nonfunctioning gut
15. Known cows milk protein intolerance
16. Psychiatric or cognitive conditions that may interfere with the study
17. Patients incapable of providing informed consent
18. Patients unlikely to comply with study requirements
19. Pregnant or breastfeeding women
20. Prisoners
Recruitment start date
12/11/2014
Recruitment end date
31/10/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Stoke Mandeville Hospital
National Spinal Injury Centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
Funders
Funder type
Industry
Funder name
Yakult Honsha Co., Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary