Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Study Overview
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Brief Summary
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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.

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

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: Entocort
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entocort EC<br>Subjects will take 6mg Entocort EC by mouth daily for 8 weeks. | Drug: Entocort<br>* A corticosteroid that decreases levels of inflammatory cytokines.<br>* Other names: budesonide;|
| Placebo Comparator: Placebo<br>Subjects will take 6mg matching placebo pill daily for 8 weeks. | Drug: Placebos<br>* Placebo is matched to the study drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission of diarrhea | Measured using symptom diary. Complete remission (CR) is defined as a mean of <3 stools/day and a mean of <1 watery stool per day without use of anti-diarrheal drugs. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). | Change from Baseline to Week 8 | 
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). | Change from Baseline to Week 16 | 
| Change in Gastrointestinal Quality of Life Index (GIQLI) | The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction. | Change from Baseline to Week 8 | 
| Change in Gastrointestinal Quality of Life Index (GIQLI) | The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction. | Change from Baseline to Week 16 | 
| MPA Dose |  | Change from Baseline to Week 8 | 
| MPA Dose |  | Change from Baseline to Week 16 |