Plasma Citrulline Concentration in Tropical Enteropathy

NCT ID: NCT00816842

Last Updated: 2009-01-05

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 1998-10-31
• Study Completion Date: 2008-09-30

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 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.

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 (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.

Conditions

Malabsorption Syndromes; Granulomatous Enteritis; Enteritis; HIV Enteropathy; Ileal Diseases

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role: lead

Responsible Party

Azienda Ospedaliera Universitaria di Parma

Principal Investigators

Cinzia Papadia, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria di Parma

Alastair Forbes, BSc MD FRCP ILTM

Role: STUDY_CHAIR

University College London Hospitals

Antonio Di Sabatino, MD

Role: STUDY_DIRECTOR

University of Pavia

Locations

Department of Medicine, University of Zambia School of Medicine, University Teaching Hospital

Lusaka, Lusaka Province, Zambia

Countries

Zambia

Other Identifiers

Prot 84 24/01/06

Identifier Type: -

Identifier Source: secondary_id

EC3184

Identifier Type: -

Identifier Source: org_study_id