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 |
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.
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
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