The effect of modulating gut microflora on clinical outcome in elective surgical patients.

ISRCTN	ISRCTN15806146
DOI	https://doi.org/10.1186/ISRCTN15806146
Protocol serial number	N0285150582
Sponsor	Department of Health
Funders	North Yorkshire Alliance R&D Unit (UK), Scarborough & NE Yorkshire Healthcare NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Bala S Reddy
Scientific

Dept of General Surgery
Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom

Phone	+44 (0)1723 368111
Email	drbalasreddy@yahoo.co.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	80
Key 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.
Key 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.
Date of first enrolment	19/07/2004
Date of final enrolment	01/10/2005

Dept of General Surgery

Scarborough
YO12 6QL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2007		Yes	No