Use of probiotic yoghurt to prevent diarrhoea in critical care: A randomised double-blind, placebo-controlled trial
| ISRCTN | ISRCTN10768531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10768531 |
| Protocol serial number | 7425 |
| Sponsor | Aintree University Hospitals NHS Foundation Trust (UK) |
| Funders | Hospital Infection Society (UK), National Institute of Academic Anaesthesia (UK) |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 30/08/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lindsay Parker
Scientific
Scientific
Aintree University Hospitals
Fazakerley Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional prevention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Use of probiotic yoghurt to prevent diarrhoea in critical care: A randomised double-blind, placebo-controlled trial |
| Study objectives | Do probiotics reduce the incidence of diarrhoea in critically ill patients taking antibiotics? |
| Ethics approval(s) | MREC, ref: 08/H1003/95 |
| Health condition(s) or problem(s) studied | Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Public Health Research |
| Intervention | Patients will be randomised to receive either one sachet of VSL#3 or placebo twice daily via their nasogastric tube, or feeding gastrostomy/jejunostomy. Probiotic/placebo administration will continue for the duration of antibiotic therapy and for a further 7 days following cessation of antibiotics. |
| Intervention type | Other |
| Primary outcome measure(s) |
Diarrhoea: defined as more than 3 loose stools per day (Bristol stool chart grade 7) |
| Key secondary outcome measure(s) |
Clostridium difficile associated disease: Clostridium difficile A or B toxin (CDT) positive stool sample |
| Completion date | 01/10/2010 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 192 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Aintree University Hospitals
Liverpool
L9 7AL
United Kingdom
L9 7AL
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/08/2016: this trial did not start because of difficulties getting a supply of the trial product.
