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

South Tees Hospitals NHS Trust
Gastroenterology Department
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn evaluation of the efficacy of the pre-biotic BENEO Synergy1 (combination oligofructose and high polymer-inulin) in the treatment of antibiotic associated diarrhoea
Study objectivesTo 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) studiedDiarrhoea
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Oligofructose, high polymer-inulin
Primary outcome measureTime 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 measuresIncidence of clinical recurrence of C. difficile infection during the period of follow up.
Overall study start date01/10/2006
Completion date30/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants134
Key inclusion criteria1. 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 criteria1. Patients unable to give informed consent
2. Restricted oral intake
3. Those with diabetes
Date of first enrolment01/10/2006
Date of final enrolment30/01/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

South Tees Hospitals NHS Trust
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

07/12/2015: no publications found on PubMed.