Plasma Citrulline Concentration in Tropical Enteropathy

Malabsorption Syndromes Clinical Trial

Official title:

Plasma Citrulline as Quantitative Biomarker of HIV Associate Villous Atrophy in a Tropical Enteropathy Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816842
• Other study ID #: EC3184
• Secondary ID: Prot 84 24/01/06
• Status: Completed
• Phase: N/A
• First received: January 2, 2009
• Last updated: January 2, 2009
• Start date: October 1998
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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 stream. The investigators have designed a study looking at the value of measuring plasma citrulline concentration in patients with tropical enteropathy of mixed HIV status. The focus will be on the ability of the intestine to sustain the individual concerned from a nutritional standpoint. The investigators hypothesise that plasma citrulline concentration is a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related enteropathy.

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 (e.g. 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 (24±13µmol/L)than in healthy subjects (40±10µmol/L)and patients with anorexia nervosa (39±9µmol/L).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 and viral infections. The plasma citrulline was shown to be a simple, non invasive and sensitive essay to monitor and quantify radiation and/or chemotherapy 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 consistent data for specific conditions as for HIV enteropathy are missing.We hypothesise that plasma citrulline concentration is a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related enteropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• histologically ascertained Tropical enteropathy

• Mixed HIV status

• Body mass index within normal range

Exclusion Criteria:

• Patients with surgical resection of stomach, duodenum or pancreas; or (UGI) bypass.

• 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

• Patients experiencing diarrhoea within one month since enrolment date

• Use of glucagon-like peptide 2 (GLP2), growth hormone (GH) or glutamine or triglycerides

• Coeliac Disease, Crohn's disease or infectious intestinal disease

• Patients on steroids or FANS

• Oral feeding>1.0-fold the estimated basal metabolic rate as assessed using Harris and Benedict equation

Study Design

N/A

Related Conditions & MeSH terms

• Crohn Disease
• Enteritis
• Granulomatous Enteritis
• HIV Enteropathy
• Ileal Diseases
• Intestinal Diseases
• Malabsorption Syndromes

Locations

Country	Name	City	State
Zambia	Department of Medicine, University of Zambia School of Medicine, University Teaching Hospital	Lusaka	Lusaka province

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postabsorptive plasma citrulline concentration		within two years since enrolment date	No
Secondary	intestinal permeability ratio		within two years since enrolment date	No