Plasma Citrulline Concentration in Tropical Enteropathy

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00816842

First Posted: January 5, 2009

Last Update Posted: January 5, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Azienda Ospedaliero-Universitaria di Parma

Purpose

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.

Condition
Malabsorption Syndromes Granulomatous Enteritis Enteritis HIV Enteropathy Ileal Diseases


Study Type:	Observational
Official Title:	Plasma Citrulline as Quantitative Biomarker of HIV Associate Villous Atrophy in a Tropical Enteropathy Population

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: HIV/AIDS

Genetic and Rare Diseases Information Center resources: Tropical Sprue

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliero-Universitaria di Parma:

Primary Outcome Measures:

postabsorptive plasma citrulline concentration [ Time Frame: within two years since enrolment date ]

Secondary Outcome Measures:

intestinal permeability ratio [ Time Frame: within two years since enrolment date ]


Study Start Date:	October 1998
Study Completion Date:	September 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Tropical enteropathy with mixed HIV status

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816842

Locations


Zambia
Department of Medicine, University of Zambia School of Medicine, University Teaching Hospital
Lusaka, Lusaka province, Zambia, P/B RW1X

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria di Parma

Investigators


Principal Investigator:	Cinzia Papadia, MD	Azienda Ospedaliero-Universitaria di Parma
Study Chair:	Alastair Forbes, BSc MD FRCP ILTM	University College London Hospitals
Study Director:	Antonio Di Sabatino, MD	University of Pavia

More Information


Responsible Party:	Cinzia Papadia, Azienda Ospedaliera Universitaria di Parma
ClinicalTrials.gov Identifier:	NCT00816842 History of Changes
Other Study ID Numbers:	EC3184 Prot 84 24/01/06
First Submitted:	January 2, 2009
First Posted:	January 5, 2009
Last Update Posted:	January 5, 2009
Last Verified:	January 2009

Keywords provided by Azienda Ospedaliero-Universitaria di Parma:


citrulline malabsorption Villous atrophy enteropathy

Additional relevant MeSH terms:


Intestinal Diseases Malabsorption Syndromes Enteritis Sprue, Tropical HIV Enteropathy Crohn Disease Ileal Diseases Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases Gastroenteritis	HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Inflammatory Bowel Diseases

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