Plasma Citrulline Concentration in Tropical Enteropathy

NCT00816842 | Completed

• 2 other identifiers: EC3184Prot 84 24/01/06
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

citrulline; malabsorption; Villous atrophy; enteropathy

Outcome Measures

Primary Outcomes (1)

• postabsorptive plasma citrulline concentration

  within two years since enrolment date

Secondary Outcomes (1)

• intestinal permeability ratio

  within two years since enrolment date

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tropical enteropathy with mixed HIV status

You may qualify if:

• histologically ascertained Tropical enteropathy
• Mixed HIV status
• Body mass index within normal range

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

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

Lusaka, Lusaka Province, P/B RW1X, Zambia

Location

MeSH Terms

Conditions

Malabsorption Syndromes; Crohn Disease; Enteritis; HIV Enteropathy; Ileal Diseases; Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Inflammatory Bowel Diseases; Gastroenteritis; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Cinzia Papadia, MD

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

• Alastair Forbes, BSc MD FRCP ILTM

  University College London Hospitals

  STUDY CHAIR

• Antonio Di Sabatino, MD

  University of Pavia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: January 5, 2009
• Study Start: October 1, 1998
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 5, 2009

Record last verified: 2009-01

Locations

ZA (1)