Efficacy of Consuming LcS In Spinal cord injury Patients (ECLISP)
| ISRCTN | ISRCTN13119162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13119162 |
| Secondary identifying numbers | 17618 |
- 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
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
Scientific
Stoke Mandeville Hospital
National Spinal Injury Centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 12/11/2014 |
| Completion date | 31/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 360; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
Sponsor information
Hospital/treatment centre
Department of R&D
Stoke Mandeville Hospital
Mandeville Road
Aylesbury
HP21 8AL
England
United Kingdom
"ROR" |
https://ror.org/037f2xv36 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 22/03/2024 | 25/03/2024 | Yes | No |
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.
