Condition category
Digestive System
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
07/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Hancock

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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