Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide
Sponsor
University Health Network, Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT02977897
Collaborator
(none)
10
1
Study Details
Study Description
Brief Summary
Prospective, observational pilot study of ten post-transplant patients presenting with diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once the diagnosis is confirmed, the patients will then be treated with a short course of subcutaneous Octreotide which has been shown to cure this type of diarrhea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide
Study Start Date
:
Jan 1, 2017
Anticipated Primary Completion Date
:
Nov 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diarrhea on MMF Solid organ transplant recipients on MMF who develop diarrhea while taking the drug. Fecal calprotectin will be measured in their stool and Octreotide Acetate will be used to treat their diarrhea. |
Drug: Octreotide Acetate
Octreotide 100mcg SC q12h for 5 days
|
Outcome Measures
Primary Outcome Measures
- Measurement of Fecal Calprotectin levels patients with diarrhea on MMF [3 months]
Secondary Outcome Measures
- Treatment of patients with MMF induced diarrhea with Octreotide [5 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Male and female patients between the ages of 18 and 75 years old who are solid organ transplant recipients followed at Toronto General Hospital on MMF referred to gastroenterology for diarrhea.
Exclusion Criteria:
-
Subjects with a known history of IBD or GVHD of the bowel.
-
Any subject receiving Octreotide for another indication.
-
Any patient unable to undergo endoscopy.
-
Any patient with a contraindication to Octreotide therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Toronto General Hospital, University Health Network | Toronto | Ontario | Canada | M5G 2N2 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000 May;47(2-3):85-118. Review.
- Arns W. Noninfectious gastrointestinal (GI) complications of mycophenolic acid therapy: a consequence of local GI toxicity? Transplant Proc. 2007 Jan-Feb;39(1):88-93. Review.
- Calmet FH, Yarur AJ, Pukazhendhi G, Ahmad J, Bhamidimarri KR. Endoscopic and histological features of mycophenolate mofetil colitis in patients after solid organ transplantation. Ann Gastroenterol. 2015 Jul-Sep;28(3):366-373.
- Feichtiger H, Wieland E, Armstrong VW, Shipkova M. The acyl glucuronide metabolite of mycophenolic acid induces tubulin polymerization in vitro. Clin Biochem. 2010 Jan;43(1-2):208-13. doi: 10.1016/j.clinbiochem.2009.08.023. Epub 2009 Sep 8.
- Ferreiro-Iglesias R, Barreiro-de Acosta M, Lorenzo-Gonzalez A, Dominguez-Muñoz JE. Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn's disease patients on maintenance treatment with adalimumab. Scand J Gastroenterol. 2016;51(4):442-7. doi: 10.3109/00365521.2015.1115546. Epub 2015 Nov 23.
- Knoll GA, MacDonald I, Khan A, Van Walraven C. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol. 2003 Sep;14(9):2381-6.
- Konikoff MR, Denson LA. Role of fecal calprotectin as a biomarker of intestinal inflammation in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Jun;12(6):524-34. Review.
- Liapis G, Boletis J, Skalioti C, Bamias G, Tsimaratou K, Patsouris E, Delladetsima I. Histological spectrum of mycophenolate mofetil-related colitis: association with apoptosis. Histopathology. 2013 Nov;63(5):649-58. doi: 10.1111/his.12222. Epub 2013 Sep 11.
- Lorenz F, Marklund S, Werner M, Palmqvist R, Wahlin BE, Wahlin A. Fecal calprotectin as a biomarker of intestinal graft versus host disease after allogeneic hematopoietic stem cell transplantation. Sci Rep. 2015 Jan 21;5:7920. doi: 10.1038/srep07920.
- Maes B, Hadaya K, de Moor B, Cambier P, Peeters P, de Meester J, Donck J, Sennesael J, Squifflet JP. Severe diarrhea in renal transplant patients: results of the DIDACT study. Am J Transplant. 2006 Jun;6(6):1466-72. Erratum in: Am J Transplant. 2007 Mar;7(3):729. Am J Transplant. 2007 May;7(5):1317.
- Sydora MJ, Sydora BC, Fedorak RN. Validation of a point-of-care desk top device to quantitate fecal calprotectin and distinguish inflammatory bowel disease from irritable bowel syndrome. J Crohns Colitis. 2012 Mar;6(2):207-14. doi: 10.1016/j.crohns.2011.08.008. Epub 2011 Sep 7.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02977897
Other Study ID Numbers:
- 16-5998
First Posted:
Nov 30, 2016
Last Update Posted:
Nov 30, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms: