Crohn's Disease Clinical Trial
Official title:
Plasma Citrulline Level: A Simple, Sensitive Method to Assess and Monitor Small Bowel Absorptive Function in Patients With Crohn's Disease?
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 Crohn’s 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 Crohn’s 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.
Status | Completed |
Enrollment | 54 |
Est. completion date | June 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Crohn's disease (CD) with massive small bowel resection at least 24 months previously (< 50cm remaining) - Crohn's disease with small bowel resection at least 24 months previously (50-150cm remaining) - CD with no resection - Mesenteric infarction with massive resection > 24 months previously (< 50cm remaining) - Mesenteric infarction with massive resection > 24 months previously (50-150cm remaining); coeliac disease. - Healthy volunteers. - Body mass index within the normal range Exclusion Criteria: - Patients with surgical resection of stomach, duodenum or pancreas; or upper gastrointestinal (UGI) bypass. - Oral feeding > 1.0-fold the estimated basal metabolic rate as assessed using Harris and Benedict equations. - Patients with fistulating Crohn's disease - Patients on steroids - Patients with other important disease, which may interfere with the study (especially diabetes and renal impairment). Alcoholism, drug abuse or any other circumstances, which may compromise the patient's ability to comply with the study requirements. - Pregnancy. - Corticosteroid use or octreotide during, or in, the month before the study. - Use of glucagon-like peptide 2 (GLP2), growth hormone (GH) or glutamine or triglycerides. |
Observational Model: Case Control, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Mark's Hospital | London | Middlesex |
Lead Sponsor | Collaborator |
---|---|
St Mark's Hospital Foundation |
United Kingdom,
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* Note: There are 15 references in all — Click here to view all references
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