Diarrhea
Conditions
Brief summary
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.
Interventions
DRUGEntocort
A corticosteroid that decreases levels of inflammatory cytokines.
DRUGPlacebos
Placebo is matched to the study drug.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission of Diarrhea | Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | Change from Baseline to Week 8 | 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 in Gastrointestinal Quality of Life Index (GIQLI) | Change from Baseline to Week 8 | 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. |
| MPA Dose | Change from Baseline to Week 8 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entocort EC Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
Entocort: A corticosteroid that decreases levels of inflammatory cytokines. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 4 |
Baseline characteristics
| Characteristic | Entocort EC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 48.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
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
Population: Data not collected. Physician left the institution and study was terminated.
Secondary
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
Population: Data not collected. Physician left the institution and study was terminated.
Secondary
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 16
Population: Data not collected. Physician left the institution and study was terminated.
Secondary
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
Population: Data not collected. Physician left the institution and study was terminated.
Secondary
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 16
Population: Data not collected. Physician left the institution and study was terminated.
Secondary
MPA Dose
Time frame: Change from Baseline to Week 16
Population: Data not collected. Physician left the institution and study was terminated.
Secondary
MPA Dose
Time frame: Change from Baseline to Week 8
Population: Data not collected. Physician left the institution and study was terminated.