Efficacy of Consuming LcS In Spinal cord injury Patients (ECLISP)

ISRCTN	ISRCTN13119162
DOI	https://doi.org/10.1186/ISRCTN13119162
Protocol serial number	17618
Sponsor	Buckinghamshire Healthcare NHS Trust
Funder	Yakult Honsha Co., Ltd

Submission date: 08/01/2015
Registration date: 12/01/2015
Last edited: 25/03/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Edmund Chiu
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	ECLISP
Study objectives	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(s)	Oxford REC, 25/09/2014, 14/SC/1101
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Occurrence of antibiotic-associated dairrhoea: Timepoint(s): 30 days
Key secondary outcome measure(s)	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.
Completion date	31/10/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	360
Total final enrolment	359
Key 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)
Key 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
Date of first enrolment	12/11/2014
Date of final enrolment	31/10/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Stoke Mandeville Hospital

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/09/2021	21/09/2021	Yes	No
Results article		22/03/2024	25/03/2024	Yes	No
HRA research summary			26/07/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/03/2024: Publication reference added.
21/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.