Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0227185807
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
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
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
Phase
Not Applicable
Drug names
Oligofructose, high polymer-inulin
Primary outcome measures
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 trial start date
01/10/2006
Overall trial end date
30/01/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
134
Participant exclusion criteria
1. Patients unable to give informed consent
2. Restricted oral intake
3. Those with diabetes
Recruitment start date
01/10/2006
Recruitment end date
30/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Tees Hospitals NHS Trust
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Tees Hospitals NHS Trust (UK)
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