Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Phase 2TerminatedNCT02991768

University of Kansas Medical Center9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diarrhea

Interventions

EntocortDRUG

A corticosteroid that decreases levels of inflammatory cytokines.

PlacebosDRUG

Placebo is matched to the study drug.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 8

Secondary Outcomes

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).

Time frame: Change from Baseline to Week 8

Change in Gastrointestinal Symptom Rating Scale (GSRS)

Time frame: 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.

Time frame: Change from Baseline to Week 8

Change in Gastrointestinal Quality of Life Index (GIQLI)

Data from ClinicalTrials.gov

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