Plasma Citrulline Concentration in Tropical Enteropathy

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.

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Key information

Conditions

Malabsorption Syndromes Blood-Borne Infections Communicable Diseases Crohn Disease Digestive System Diseases Enteritis Gastroenteritis Gastrointestinal Diseases Genital Diseases Granulomatous Enteritis HIV Enteropathy HIV Infections Ileal Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammatory Bowel Diseases Intestinal Diseases Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lusaka, Lusaka Province, P/B RW1X, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

postabsorptive plasma citrulline concentration

Time frame: within two years since enrolment date

Secondary outcomes

intestinal permeability ratio

Time frame: within two years since enrolment date

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Official study title

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

Important dates

Study start: 1998
Primary completion: 2008
Study completion: 2008
First posted: Jan 5, 2009
Registry last updated: Jan 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed