Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/08/2008
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

Mr Bala S Reddy

ORCID ID

Contact details

Dept of General Surgery
Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom
+44 (0)1723 368111
drbalasreddy@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0285150582

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to investigate whether or not modulation of gastrointestinal microflora might impact upon septic morbidity in surgical patients?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Sepsis

Intervention

Patients will be recruited from the elective colorectal admissions at Scarborough Hospital and will be randomised by a series of sealed envelopes into one of the four groups when they are seen in the pre-assessment clinic.

Group 1 - Control group.
Group 2 - Will receive Neomycin prior to surgery plus bowel preparation.
Group 3 - Neomycin, bowel prep, plus synbiotics. Group 4 - Neomycin, symbiotics but no bowel preparation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Gut microflora:
1. Nasogastric aspirate
2. Fecal samples.

Gut barrier function:
1. Bacterial Translocation
2. Intestinal Permeability.

Inflammatory response:
1. C reactive protein (CRP)
2. Interleukin-6 (IL-6)
3. AntiEndotoxin core antibody (IgM Endo CAB).

Septic morbidity:
1. Wound infection
2. Intra-abdominal abscess
3. Chest Infection
4. UTI.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/07/2004

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Using bacterial translocation as the primary end point for sample size calculation, if the sample size in each of the 4 groups is 20, alpha=0.05 (2-tailed) a chi-square test will have 80% power to detect a difference in proportions.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Failure to obtain informed consent, patients with co-existing infections, patients on antibiotics in the previous 2 weeks before recruitment and patients with severe hepatic or renal failure.

Recruitment start date

19/07/2004

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of General Surgery
Scarborough
YO12 6QL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

North Yorkshire Alliance R&D Unit (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Scarborough & NE Yorkshire Healthcare 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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17443852

Publication citations

  1. Results

    Reddy BS, Macfie J, Gatt M, Larsen CN, Jensen SS, Leser TD, Randomized clinical trial of effect of synbiotics, neomycin and mechanical bowel preparation on intestinal barrier function in patients undergoing colectomy., Br J Surg, 2007, 94, 5, 546-554, doi: 10.1002/bjs.5705.

Additional files

Editorial Notes