Crohn's DiseaseNCT00138879
Citrulline: A Plasmatic Marker to Assess and Monitor Small Bowel Crohn's Disease Patients
An observational study of Crohn's Disease and Short Bowel Syndrome, run by St Mark's Hospital Foundation at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Short Bowel Syndrome, Malabsorption Syndromes
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2003to Jun 2005
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Crohn's disease (CD) with massive small bowel resection at least 24 months previously (< 50cm remaining)
- Crohn's disease with small bowel resection at least 24 months previously (50-150cm remaining)
- CD with no resection
- Mesenteric infarction with massive resection > 24 months previously (< 50cm remaining)
- Mesenteric infarction with massive resection > 24 months previously (50-150cm remaining); coeliac disease.
- Healthy volunteers.
- Body mass index within the normal range
Who cannot join
- Patients with surgical resection of stomach, duodenum or pancreas; or upper gastrointestinal (UGI) bypass.
- Oral feeding > 1.0-fold the estimated basal metabolic rate as assessed using Harris and Benedict equations.
- Patients with fistulating Crohn's disease
- Patients on steroids
- 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.
- Corticosteroid use or octreotide during, or in, the month before the study.
- Use of glucagon-like peptide 2 (GLP2), growth hormone (GH) or glutamine or triglycerides.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Citrulline Level: A Simple, Sensitive Method to Assess and Monitor Small Bowel Absorptive Function in Patients With Crohn's Disease?
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. The investigators have designed a study looking at the value of measuring plasma citrulline concentration in patients with Crohn's disease and short bowel or normal intestinal length. Measuring the plasma citrulline concentration in short bowel patients may help to distinguish between patients who need permanent parenteral feeding from patients with just transient intestinal dysfunction. It may also help the investigators in understanding the small bowel intestinal length remaining and the absorptive integrity. In patients with normal intestinal length and Crohn's disease, it may be a reliable marker of small bowel damage and could be applied to establish therapeutic improvements. It has been demonstrated to strongly correlate (inversely) with severity on intestinal biopsies.
The investigators hypothesise that the plasma citrulline concentration is a marker for small bowel absorptive integrity and an appropriate surrogate for functional length of the small intestine.
Controlled data do not yet exist to establish the place of plasma citrulline in the assessment of small bowel function in man.
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±13 μmol/L) than in healthy subjects (40±10 μmol/L) and patients with anorexia nervosa (39±9).
A citrulline threshold of 20 µmol/L apparently permitted the classification of short bowel syndrome patients into either transient or permanent intestinal failure categories, with 92% sensitivity, 90% specificity, and 95% positive and 86% negative predictive values, respectively. 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. The plasma citrulline was shown to be a simple, non-invasive and sensitive assay to monitor and quantify radiation-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 data for specific conditions come only from single centres; there are limited data on normal ranges. More crucially, however, there has been no attempt to clarify the effect of inflammation on citrulline homeostasis. To date there is no information in respect of patients with intestinal failure in whom there has been no resection.
We hypothesise that plasma citrulline concentration reflects small bowel absorptive capacity and correlates to the functional intestinal length independently from inflammation.
Comparisons: To exclude the possibility that citrulline merely reflects inflammation, control groups (six subjects each) with short bowel syndrome without inflammation (mesenteric infarct) (negative control); and those with inflammation but no anatomical loss (active coeliac disease) (positive controls); will be studied as well as healthy volunteers.
The study is designed to utilise patients from the positive and negative control groups to permit a correlation of plasma citrulline with intestinal length and with a "gold standard" assessment of intestinal function as judged from the patients need for nutritional intervention (from normal diet to dependence on home parenteral nutrition).
Plasma citrulline will be determined by Reverse-phase High Performance Liquid Chromatography (RF-HPLC) after an overnight fast. Albumin and Routine biochemical assessment will also be performed. Gastrointestinal permeability will be determined from the double sugar test using rhamnose and lactulose, and functional absorptive capacity will be estimated by D-Xylose absorption rate.
Analysis will allow for paired comparison between patients and between groups. Differences in the clinical performance of the various parameters will be determined. The study has adequate statistical power.
- Keywords
- Citrulline, Parenteral Nutrition, functioning intestinal mass, small bowel permeability and absorption, Granulomatous Enteritis
- Medical subject headings
- Crohn Disease, Short Bowel Syndrome, Malabsorption Syndromes, Celiac Disease, Hyperphagia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMay 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- St Mark's Hospital Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Alastair Forbes, Medicine, Study chair, University College, LondonRoy A. Sherwood, Biochemistry, Study director, King's College Hospital NHS TrustCinzia Papadia, Medicine, Principal investigator, Imperial College University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138879
- Sponsor's protocol ID
- EC3155
- Status last verified
- Aug 2005
- First submitted
- 29 Aug 2005
- Last updated
- 15 Dec 2005
- Results posted
- No
Publications
Blijlevens NM, Lutgens LC, Schattenberg AV, Donnelly JP. Citrulline: a potentially simple quantitative marker of intestinal epithelial damage following myeloablative therapy. Bone Marrow Transplant. 2004 Aug;34(3):193-6. doi: 10.1038/sj.bmt.1704563.
PubMed 15170165Lutgens LC, Deutz NE, Gueulette J, Cleutjens JP, Berger MP, Wouters BG, von Meyenfeldt MF, Lambin P. Citrulline: a physiologic marker enabling quantitation and monitoring of epithelial radiation-induced small bowel damage. Int J Radiat Oncol Biol Phys. 2003 Nov 15;57(4):1067-74. doi: 10.1016/s0360-3016(03)00781-8.
PubMed 14575838Pappas PA, Tzakis AG, Saudubray JM, Gaynor JJ, Carreno MR, Huijing F, Kleiner G, Rabier D, Kato T, Levi DM, Nishida S, Gelman B, Thompson JF, Mittal N, Ruiz P. Trends in serum citrulline and acute rejection among recipients of small bowel transplants. Transplant Proc. 2004 Mar;36(2):345-7. doi: 10.1016/j.transproceed.2003.12.007.
PubMed 15050154Selvaggi G, Weppler D, Tzakis A. Liver and gastrointestinal transplantation at the University of Miami. Clin Transpl. 2003:255-66.
PubMed 15387117Pappas PA, G Tzakis A, Gaynor JJ, Carreno MR, Ruiz P, Huijing F, Kleiner G, Rabier D, Kato T, Levi DM, Nishida S, Gelman B, Thompson JF, Mittal N, Saudubray JM. An analysis of the association between serum citrulline and acute rejection among 26 recipients of intestinal transplant. Am J Transplant. 2004 Jul;4(7):1124-32. doi: 10.1111/j.1600-6143.2004.00469.x.
PubMed 15196071Pappas PA, Saudubray JM, Tzakis AG, Rabier D, Carreno MR, Gomez-Marin O, Huijing F, Gelman B, Levi DM, Nery JR, Kato T, Mittal N, Nishida S, Thompson JF, Ruiz P. Serum citrulline as a marker of acute cellular rejection for intestinal transplantation. Transplant Proc. 2002 May;34(3):915-7. doi: 10.1016/s0041-1345(02)02668-4. No abstract available.
PubMed 12034237Crenn P, Vahedi K, Lavergne-Slove A, Cynober L, Matuchansky C, Messing B. Plasma citrulline: A marker of enterocyte mass in villous atrophy-associated small bowel disease. Gastroenterology. 2003 May;124(5):1210-9. doi: 10.1016/s0016-5085(03)00170-7.
PubMed 12730862Crenn P, Coudray-Lucas C, Thuillier F, Cynober L, Messing B. Postabsorptive plasma citrulline concentration is a marker of absorptive enterocyte mass and intestinal failure in humans. Gastroenterology. 2000 Dec;119(6):1496-505. doi: 10.1053/gast.2000.20227.
PubMed 11113071Windmueller HG, Spaeth AE. Source and fate of circulating citrulline. Am J Physiol. 1981 Dec;241(6):E473-80. doi: 10.1152/ajpendo.1981.241.6.E473.
PubMed 7325229Nightingale JM, Bartram CI, Lennard-Jones JE. Length of residual small bowel after partial resection: correlation between radiographic and surgical measurements. Gastrointest Radiol. 1991 Fall;16(4):305-6. doi: 10.1007/BF01887374.
PubMed 1936771D'Antiga L, Dhawan A, Davenport M, Mieli-Vergani G, Bjarnason I. Intestinal absorption and permeability in paediatric short-bowel syndrome: a pilot study. J Pediatr Gastroenterol Nutr. 1999 Nov;29(5):588-93. doi: 10.1097/00005176-199911000-00021.
PubMed 10554128Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
PubMed 3820522Zhang WZ, Kaye DM. Simultaneous determination of arginine and seven metabolites in plasma by reversed-phase liquid chromatography with a time-controlled ortho-phthaldialdehyde precolumn derivatization. Anal Biochem. 2004 Mar 1;326(1):87-92. doi: 10.1016/j.ab.2003.11.006.
PubMed 14769339Sherwood RA. Amino acid measurement by high-performance liquid chromatography using electrochemical detection. J Neurosci Methods. 1990 Sep;34(1-3):17-22. doi: 10.1016/0165-0270(90)90037-g.
PubMed 2259239Sherwood RA, Titheradge AC, Richards DA. Measurement of plasma and urine amino acids by high-performance liquid chromatography with electrochemical detection using phenylisothiocyanate derivatization. J Chromatogr. 1990 Jun 29;528(2):293-303. doi: 10.1016/s0378-4347(00)82388-9.
PubMed 2384569
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Citrulline Level: A Simple, Sensitive Method to Assess and Monitor Small Bowel Absorptive Function in Patients With Crohn's Disease?
- ClinicalTrials.gov ID
- NCT00138879
- Acronym / sponsor ID
- EC3155
- Keywords
- Citrulline, Parenteral Nutrition, functioning intestinal mass, small bowel permeability and absorption, Granulomatous Enteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- St Mark's Hospital FoundationUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Jun 2005
- First posted
- 30 Aug 2005 (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. The investigators have designed a study looking at the value of measuring plasma citrulline concentration in patients with Crohn's disease and short bowel or normal intestinal length. Measuring the plasma citrulline concentration in short bowel patients may help to distinguish between patients who need permanent parenteral feeding from patients with just transient intestinal dysfunction. It may also help the investigators in understanding the small bowel intestinal length remaining and the absorptive integrity. In patients with normal intestinal length and Crohn's disease, it may be a reliable marker of small bowel damage and could be applied to establish therapeutic improvements. It has been demonstrated to strongly correlate (inversely) with severity on intestinal biopsies.
The investigators hypothesise that the plasma citrulline concentration is a marker for small bowel absorptive integrity and an appropriate surrogate for functional length of the small intestine.
Controlled data do not yet exist to establish the place of plasma citrulline in the assessment of small bowel function in man.
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±13 μmol/L) than in healthy subjects (40±10 μmol/L) and patients with anorexia nervosa (39±9).
A citrulline threshold of 20 µmol/L apparently permitted the classification of short bowel syndrome patients into either transient or permanent intestinal failure categories, with 92% sensitivity, 90% specificity, and 95% positive and 86% negative predictive values, respectively. 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. The plasma citrulline was shown to be a simple, non-invasive and sensitive assay to monitor and quantify radiation-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 data for specific conditions come only from single centres; there are limited data on normal ranges. More crucially, however, there has been no attempt to clarify the effect of inflammation on citrulline homeostasis. To date there is no information in respect of patients with intestinal failure in whom there has been no resection.
We hypothesise that plasma citrulline concentration reflects small bowel absorptive capacity and correlates to the functional intestinal length independently from inflammation.
Comparisons: To exclude the possibility that citrulline merely reflects inflammation, control groups (six subjects each) with short bowel syndrome without inflammation (mesenteric infarct) (negative control); and those with inflammation but no anatomical loss (active coeliac disease) (positive controls); will be studied as well as healthy volunteers.
The study is designed to utilise patients from the positive and negative control groups to permit a correlation of plasma citrulline with intestinal length and with a "gold standard" assessment of intestinal function as judged from the patients need for nutritional intervention (from normal diet to dependence on home parenteral nutrition).
Plasma citrulline will be determined by Reverse-phase High Performance Liquid Chromatography (RF-HPLC) after an overnight fast. Albumin and Routine biochemical assessment will also be performed. Gastrointestinal permeability will be determined from the double sugar test using rhamnose and lactulose, and functional absorptive capacity will be estimated by D-Xylose absorption rate.
Analysis will allow for paired comparison between patients and between groups. Differences in the clinical performance of the various parameters will be determined. The study has adequate statistical power.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Crohn's disease (CD) with massive small bowel resection at least 24 months previously (< 50cm remaining)
- Crohn's disease with small bowel resection at least 24 months previously (50-150cm remaining)
- CD with no resection
- Mesenteric infarction with massive resection > 24 months previously (< 50cm remaining)
- Mesenteric infarction with massive resection > 24 months previously (50-150cm remaining); coeliac disease.
Key exclusion criteria (8 listed)
- Patients with surgical resection of stomach, duodenum or pancreas; or upper gastrointestinal (UGI) bypass.
- Oral feeding > 1.0-fold the estimated basal metabolic rate as assessed using Harris and Benedict equations.
- Patients with fistulating Crohn's disease
- Patients on steroids
- 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.
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
Not reported in the source record.
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 15 Dec 2005.
- Background: PubMed 15170165Blijlevens NM, Lutgens LC, Schattenberg AV, Donnelly JP. Citrulline: a potentially simple quantitative marker of intestinal epithelial damage following myeloablative therapy. Bone Marrow Transplant. 2004 Aug;34(3):193-6. doi: 10.1038/sj.bmt.1704563.
- Background: PubMed 14575838Lutgens LC, Deutz NE, Gueulette J, Cleutjens JP, Berger MP, Wouters BG, von Meyenfeldt MF, Lambin P. Citrulline: a physiologic marker enabling quantitation and monitoring of epithelial radiation-induced small bowel damage. Int J Radiat Oncol Biol Phys. 2003 Nov 15;57(4):1067-74. doi: 10.1016/s0360-3016(03)00781-8.
- Background: PubMed 15050154Pappas PA, Tzakis AG, Saudubray JM, Gaynor JJ, Carreno MR, Huijing F, Kleiner G, Rabier D, Kato T, Levi DM, Nishida S, Gelman B, Thompson JF, Mittal N, Ruiz P. Trends in serum citrulline and acute rejection among recipients of small bowel transplants. Transplant Proc. 2004 Mar;36(2):345-7. doi: 10.1016/j.transproceed.2003.12.007.
- Background: PubMed 15387117Selvaggi G, Weppler D, Tzakis A. Liver and gastrointestinal transplantation at the University of Miami. Clin Transpl. 2003:255-66.
- Background: PubMed 15196071Pappas PA, G Tzakis A, Gaynor JJ, Carreno MR, Ruiz P, Huijing F, Kleiner G, Rabier D, Kato T, Levi DM, Nishida S, Gelman B, Thompson JF, Mittal N, Saudubray JM. An analysis of the association between serum citrulline and acute rejection among 26 recipients of intestinal transplant. Am J Transplant. 2004 Jul;4(7):1124-32. doi: 10.1111/j.1600-6143.2004.00469.x.
- Background: PubMed 12034237Pappas PA, Saudubray JM, Tzakis AG, Rabier D, Carreno MR, Gomez-Marin O, Huijing F, Gelman B, Levi DM, Nery JR, Kato T, Mittal N, Nishida S, Thompson JF, Ruiz P. Serum citrulline as a marker of acute cellular rejection for intestinal transplantation. Transplant Proc. 2002 May;34(3):915-7. doi: 10.1016/s0041-1345(02)02668-4. No abstract available.
- Background: PubMed 12730862Crenn P, Vahedi K, Lavergne-Slove A, Cynober L, Matuchansky C, Messing B. Plasma citrulline: A marker of enterocyte mass in villous atrophy-associated small bowel disease. Gastroenterology. 2003 May;124(5):1210-9. doi: 10.1016/s0016-5085(03)00170-7.
- Background: PubMed 11113071Crenn P, Coudray-Lucas C, Thuillier F, Cynober L, Messing B. Postabsorptive plasma citrulline concentration is a marker of absorptive enterocyte mass and intestinal failure in humans. Gastroenterology. 2000 Dec;119(6):1496-505. doi: 10.1053/gast.2000.20227.
- Background: PubMed 7325229Windmueller HG, Spaeth AE. Source and fate of circulating citrulline. Am J Physiol. 1981 Dec;241(6):E473-80. doi: 10.1152/ajpendo.1981.241.6.E473.
- Background: PubMed 1936771Nightingale JM, Bartram CI, Lennard-Jones JE. Length of residual small bowel after partial resection: correlation between radiographic and surgical measurements. Gastrointest Radiol. 1991 Fall;16(4):305-6. doi: 10.1007/BF01887374.
- Background: PubMed 10554128D'Antiga L, Dhawan A, Davenport M, Mieli-Vergani G, Bjarnason I. Intestinal absorption and permeability in paediatric short-bowel syndrome: a pilot study. J Pediatr Gastroenterol Nutr. 1999 Nov;29(5):588-93. doi: 10.1097/00005176-199911000-00021.
- Background: PubMed 3820522Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
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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.
Alastair Forbes, Medicine study chair
University College, London
Roy A. Sherwood, Biochemistry study director
King's College Hospital NHS Trust
Cinzia Papadia, Medicine principal investigator
Imperial College University of London
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 Crohn's Disease and Short Bowel Syndrome, run by St Mark's Hospital Foundation at 1 site in United Kingdom.
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 7 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 15 Dec 2005. 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 United Kingdom. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00138879, which also lists 15 linked publications.
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 15 Dec 2005.