Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 27, 2017
End Date:April 2019
Contact:Kenya Mitchell
Email:kmitchell5@kumc.edu
Phone:913-945-7946

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Budesonide for Mycophenolic Acid (MPA)-Induced Diarrhea in Renal Transplant Recipients

The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will
be effective and safe for kidney transplant patients, allowing them to continue with MPA
medication.


Inclusion Criteria:

- Kidney transplant recipients > 1 months post-transplant,

- No history of chronic diarrhea pre-transplant,

- >3 watery/soft stools after transplant on at least 4 days in the week without
anti-diarrheal for at least 2 weeks or using anti-diarrheals for at least 4 days in
the week > 2 weeks

- Subjects on at least 180mg twice a day of mycophenolate-sodium or 250 mg twice a day
of cellcept

Exclusion Criteria:

- Diagnosis of any known colonic diseases (i.e. Crohn's disease, ulcerative colitis,
ischemic colitis, Celiac disease), partial colonic resection, small bowel resection,
history of cholecystectomy, Irritable Bowel Syndrome, fecal Incontinence, Bacterial
overgrowth, infectious diarrhea (c difficle, cryptospora, giardia, isospora, Human
Immunodeficiency Virus), Cytomegalovirus colitis

- Subjects with recent acute rejection treated with high dose steroids

- Subjects taking Boswellia serrata extract, over-the-counter herbs, cholestyramine,
nonsteroidal salicylates (other than daily ASA)

- Subjects with active malignancy, liver cirrhosis, active peptic ulcer disease, known
intolerance or resistance to budesonide, pregnancy, breast-feeding, mental retardation

- Unable to provide informed consent
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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