Trial record 11 of 18 for:    " December 03, 2008":" January 02, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Plasma Citrulline Concentration in Tropical Enteropathy

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier:
NCT00816842
First received: January 2, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intestinal permeability ratio [ Time Frame: within two years since enrolment date ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 2, 2009
Last Updated: January 2, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Azienda Ospedaliero-Universitaria di Parma:
citrulline
malabsorption
Villous atrophy
enteropathy

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

ClinicalTrials.gov processed this record on August 26, 2014