Malabsorption SyndromesNCT00816842
Plasma Citrulline Concentration in Tropical Enteropathy
An observational study of Malabsorption Syndromes and Granulomatous Enteritis, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malabsorption Syndromes, Granulomatous Enteritis, Enteritis
- How many people
- Not given
- Where
- 1 siteZambia
- Study dates
- Oct 1998to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tropical enteropathy with mixed HIV status
Who may be able to join
- histologically ascertained Tropical enteropathy
- Mixed HIV status
- Body mass index within normal range
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Department of Medicine, University of Zambia School of Medicine, University Teaching Hospital
Lusaka, Lusaka Province, P/B RW1X
About this study
Official title: Plasma Citrulline as Quantitative Biomarker of HIV Associate Villous Atrophy in a Tropical Enteropathy Population
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.
Read the 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
- Keywords
- citrulline, malabsorption, Villous atrophy, enteropathy
- Medical subject headings
- Malabsorption Syndromes, Crohn Disease, Enteritis, HIV Enteropathy, Ileal Diseases, Intestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
postabsorptive plasma citrulline concentration
Measured: within two years since enrolment date
Secondary outcomes (1)
intestinal permeability ratio
Measured: within two years since enrolment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startOct 1998
- Primary completionMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malabsorption SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Investigators
- Cinzia Papadia, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaAlastair Forbes, BSc MD FRCP ILTM, Study chair, University College London HospitalsAntonio Di Sabatino, MD, Study director, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816842
- Sponsor's protocol ID
- EC3184
- Other IDs
- Prot 84 24/01/06
- Status last verified
- Jan 2009
- First submitted
- 2 Jan 2009
- Last updated
- 5 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Citrulline as Quantitative Biomarker of HIV Associate Villous Atrophy in a Tropical Enteropathy Population
- ClinicalTrials.gov ID
- NCT00816842
- Acronym / sponsor ID
- EC3184
- Conditions
- Malabsorption Syndromes, Granulomatous Enteritis, Enteritis, HIV Enteropathy, Ileal Diseases
- Keywords
- citrulline, malabsorption, Villous atrophy, enteropathy
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- Oct 1998
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tropical enteropathy with mixed HIV status
Key inclusion criteria (3 listed)
- histologically ascertained Tropical enteropathy
- Mixed HIV status
- Body mass index within normal range
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postabsorptive plasma citrulline concentration
Time frame: within two years since enrolment date
1 secondary outcome
intestinal permeability ratio
Time frame: within two years since enrolment date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
Related trials for Malabsorption Syndromes
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cinzia Papadia, MD principal investigator
Azienda Ospedaliero-Universitaria di Parma
Alastair Forbes, BSc MD FRCP ILTM study chair
University College London Hospitals
Antonio Di Sabatino, MD study director
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malabsorption Syndromes and Granulomatous Enteritis, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postabsorptive plasma citrulline concentration (time frame: within two years since enrolment date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2009.