An evaluation of the efficacy of the pre-biotic BENEO Synergy1 (combination oligofructose and high polymer-inulin) in the treatment of antibiotic associated diarrhoea
| ISRCTN | ISRCTN36157647 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36157647 |
| Secondary identifying numbers | N0227185807 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 07/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 John Hancock
Scientific
Scientific
South Tees Hospitals NHS Trust
Gastroenterology Department
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| 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 | An evaluation of the efficacy of the pre-biotic BENEO Synergy1 (combination oligofructose and high polymer-inulin) in the treatment of antibiotic associated diarrhoea |
| Study objectives | To investigate whether the duration of antibiotic-associated diarrhoea and clostridium difficile infection can be reduced by the use of the pre-biotic BENEO synergy 1. Secondary Research Objective: Can the recurrence of Clostridium difficile diarrhoea be reduced by using the prebiotic BENEO synergy 1? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diarrhoea |
| Intervention | This trial will be piloted in the three medical ward at the Friarage Hospital, Northallerton prior to extension to wards 3, 4 and 12 at James Cook University Hospital (SJUH). These three wards specialise in healthcare for the elderly and have proportionately high rates of C. difficile infection. Other clinical trials using fructans have shown that 12 grams a day provides an effective though easily tolerated dose. The Friarage Hospital pharmacy has agreed to issue the Synergy 1 or Sucrose placebo according to computer randomisation. The pharmacy at SJUH will also be approached prior to extension there. The powders will be in numbered but otherwise identical containers; the pharmacy will keep the key. Patients will be provided with a 28-day course of the synergy 1. As synergy 1 is a food supplement and not a drug it will not be necessary for patients primary clinician to prescribe the supplement. It is hoped that nurses will be able to administer the treatment. This is to be achieved with a supplementary prescribing form attached to the patient's drug card. Awareness of the trial will be disseminated as widely as possible particularly amongst nursing staff on the target wards, and approval will be requested from all relevant consultants prior to starting the trial. The infection control nurses at Friarage Hospital have also agreed to participate. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oligofructose, high polymer-inulin |
| Primary outcome measure | Time to discontinuation of diarrhoea defined as greater than 3 loose stools in 24 hours. As would be standard clinical practice, all patients must have a baseline stool sample to check for C. difficile infection. |
| Secondary outcome measures | Incidence of clinical recurrence of C. difficile infection during the period of follow up. |
| Overall study start date | 01/10/2006 |
| Completion date | 30/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 134 |
| Key inclusion criteria | 1. Patients isolated or barrier nursed as a result of diarrhoea 2. Have received antibiotics in the preceding week 3. Able to give informed consent |
| Key exclusion criteria | 1. Patients unable to give informed consent 2. Restricted oral intake 3. Those with diabetes |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 30/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
South Tees Hospitals NHS Trust
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
South Tees Hospitals NHS Trust (UK)
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 |
Editorial Notes
07/12/2015: no publications found on PubMed.
