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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide Acetate | Drug | Octreotide 100mcg SC q12h for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Fecal Calprotectin levels patients with diarrhea on MMF | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of patients with MMF induced diarrhea with Octreotide | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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Males and females between the ages of 18 and 75 years who are solid organ transplant recipients on mycophenolate mofetil (MMF) referred to gastroenterology at Toronto General Hospital for diarrhea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flavio Habal, MD | Contact | 4163405023 | dr.flavio.habal@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital, University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16686772 | Background | 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. doi: 10.1111/j.1600-6143.2006.01320.x. | |
| 10878285 | Background | Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000 May;47(2-3):85-118. doi: 10.1016/s0162-3109(00)00188-0. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| 12937317 | Background | 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. doi: 10.1097/01.asn.0000079616.71891.f5. |
| 17275481 | Background | 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. doi: 10.1016/j.transproceed.2006.10.189. |
| 19744471 | Background | 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. |
| 26126799 | Background | 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. |
| 24025088 | Background | 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. |
| 22325175 | Background | 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. |
| 26595391 | Background | Ferreiro-Iglesias R, Barreiro-de Acosta M, Lorenzo-Gonzalez A, Dominguez-Munoz 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. |
| 25605402 | Background | 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. |
| 16775498 | Background | 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. doi: 10.1097/00054725-200606000-00013. |
| D000602 |
| Amino Acids, Peptides, and Proteins |