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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15806146
Enrollment
80
Registered
2005-09-30
Start date
2004-07-19
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Signs and Symptoms: Sepsis Signs and Symptoms Sepsis

Interventions

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

Sponsors

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026