Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138879
Status:
COMPLETED
Last Update Posted:
2005-12-15
First Post:
2005-08-29
Brief Title:
Citrulline A Plasmatic Marker to Assess and Monitor Small Bowel Crohns Disease Patients
Sponsor:
St Marks Hospital Foundation
Organization:
St Marks Hospital Foundation
Study Overview
Official Title:
Plasma Citrulline Level A Simple Sensitive Method to Assess and Monitor Small Bowel Absorptive Function in Patients With Crohns Disease
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Citrulline is an amino acid produced in the intestine and in the liver but the liver does not contribute significantly to circulating citrulline concentrations The intestine is thus the only organ that normally releases significant amounts of citrulline into the blood The investigators have designed a study looking at the value of measuring plasma citrulline concentration in patients with Crohns disease and short bowel or normal intestinal length Measuring the plasma citrulline concentration in short bowel patients may help to distinguish between patients who need permanent parenteral feeding from patients with just transient intestinal dysfunction It may also help the investigators in understanding the small bowel intestinal length remaining and the absorptive integrity In patients with normal intestinal length and Crohns disease it may be a reliable marker of small bowel damage and could be applied to establish therapeutic improvements It has been demonstrated to strongly correlate inversely with severity on intestinal biopsies
The investigators hypothesise that the plasma citrulline concentration is a marker for small bowel absorptive integrity and an appropriate surrogate for functional length of the small intestine
Controlled data do not yet exist to establish the place of plasma citrulline in the assessment of small bowel function in man
The investigators hypothesise that the plasma citrulline concentration is a marker for small bowel absorptive integrity and an appropriate surrogate for functional length of the small intestine
Controlled data do not yet exist to establish the place of plasma citrulline in the assessment of small bowel function in man
Detailed Description:
Preliminary studies reported that plasma citrulline concentrations may be a reliable biochemical marker for intestinal dysfunction and absorptive enterocyte mass The relationship between citrulline concentration and intestinal function has been supported in other studies including those examining rejection in small bowel allografts Concentrations of citrulline are dramatically reduced in cases of mucosal damage eg moderate graft rejection or viral enteritis and strongly correlate inversely with severity on biopsy Plasma citrulline concentration is lower also in patients with villous atrophy 2413 μmolL than in healthy subjects 4010 μmolL and patients with anorexia nervosa 399
A citrulline threshold of 20 µmolL apparently permitted the classification of short bowel syndrome patients into either transient or permanent intestinal failure categories with 92 sensitivity 90 specificity and 95 positive and 86 negative predictive values respectively Experimental studies have been carried out also in assessing the value of citrulline as a marker for severity of small bowel epithelial damage from radiation The plasma citrulline was shown to be a simple non-invasive and sensitive assay to monitor and quantify radiation-induced small bowel damage in mice and humans Otherwise the literature on citrulline as a potential marker of intestinal and nutritional integrity is young and data for specific conditions come only from single centres there are limited data on normal ranges More crucially however there has been no attempt to clarify the effect of inflammation on citrulline homeostasis To date there is no information in respect of patients with intestinal failure in whom there has been no resection
We hypothesise that plasma citrulline concentration reflects small bowel absorptive capacity and correlates to the functional intestinal length independently from inflammation
Comparisons To exclude the possibility that citrulline merely reflects inflammation control groups six subjects each with short bowel syndrome without inflammation mesenteric infarct negative control and those with inflammation but no anatomical loss active coeliac disease positive controls will be studied as well as healthy volunteers
The study is designed to utilise patients from the positive and negative control groups to permit a correlation of plasma citrulline with intestinal length and with a gold standard assessment of intestinal function as judged from the patients need for nutritional intervention from normal diet to dependence on home parenteral nutrition
Plasma citrulline will be determined by Reverse-phase High Performance Liquid Chromatography RF-HPLC after an overnight fast Albumin and Routine biochemical assessment will also be performed Gastrointestinal permeability will be determined from the double sugar test using rhamnose and lactulose and functional absorptive capacity will be estimated by D-Xylose absorption rate
Analysis will allow for paired comparison between patients and between groups Differences in the clinical performance of the various parameters will be determined The study has adequate statistical power
A citrulline threshold of 20 µmolL apparently permitted the classification of short bowel syndrome patients into either transient or permanent intestinal failure categories with 92 sensitivity 90 specificity and 95 positive and 86 negative predictive values respectively Experimental studies have been carried out also in assessing the value of citrulline as a marker for severity of small bowel epithelial damage from radiation The plasma citrulline was shown to be a simple non-invasive and sensitive assay to monitor and quantify radiation-induced small bowel damage in mice and humans Otherwise the literature on citrulline as a potential marker of intestinal and nutritional integrity is young and data for specific conditions come only from single centres there are limited data on normal ranges More crucially however there has been no attempt to clarify the effect of inflammation on citrulline homeostasis To date there is no information in respect of patients with intestinal failure in whom there has been no resection
We hypothesise that plasma citrulline concentration reflects small bowel absorptive capacity and correlates to the functional intestinal length independently from inflammation
Comparisons To exclude the possibility that citrulline merely reflects inflammation control groups six subjects each with short bowel syndrome without inflammation mesenteric infarct negative control and those with inflammation but no anatomical loss active coeliac disease positive controls will be studied as well as healthy volunteers
The study is designed to utilise patients from the positive and negative control groups to permit a correlation of plasma citrulline with intestinal length and with a gold standard assessment of intestinal function as judged from the patients need for nutritional intervention from normal diet to dependence on home parenteral nutrition
Plasma citrulline will be determined by Reverse-phase High Performance Liquid Chromatography RF-HPLC after an overnight fast Albumin and Routine biochemical assessment will also be performed Gastrointestinal permeability will be determined from the double sugar test using rhamnose and lactulose and functional absorptive capacity will be estimated by D-Xylose absorption rate
Analysis will allow for paired comparison between patients and between groups Differences in the clinical performance of the various parameters will be determined The study has adequate statistical power
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None