Condition category
Infections and Infestations
Date applied
08/01/2015
Date assigned
12/01/2015
Last edited
08/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Edmund Chiu

ORCID ID

Contact details

Stoke Mandeville Hospital
National Spinal Injury Centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom

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. Non–functioning 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

Sponsor information

Organisation

Buckinghamshire Healthcare NHS Trust

Sponsor details

Department of R&D
Stoke Mandeville Hospital
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes