Trial Outcomes & Findings for Budesonide in Patients With Immune Mediated Enteropathies (NCT NCT03866538)
NCT ID: NCT03866538
Last Updated: 2022-08-26
Results Overview
Investigators will determine change in small bowel villi after withdrawal of budesonide compared to continued therapy to assess small intestinal injury. This will be accomplished by esophagogastroduodenoscopy (upper scope) with biopsies from the small intestine.
TERMINATED
PHASE4
1 participants
12 weeks
2022-08-26
Participant Flow
Participant milestones
| Measure |
Continued Budesonide
Patients in this arm continued budesonide at the dose they were taking at the time of enrollment in the trial
|
Withdrawal of Budesonide
Patients were weaned off of budesonide over 2 weeks and continued off of the medication for the duration of the trial
Withdrawal of Oral Budesonide: The intervention arm tapered and stoped budesonide therapy (withdrawal).
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Budesonide in Patients With Immune Mediated Enteropathies
Baseline characteristics by cohort
| Measure |
Continued Budesonide
Patients in this arm continued budesonide at the dose they were taking at the time of enrollment in the trial
|
Withdrawal of Budesonide
n=1 Participants
Patients were weaned off of budesonide over 2 weeks and continued off of the medication for the duration of the trial
Withdrawal of Oral Budesonide: The intervention arm tapered and stoped budesonide therapy (withdrawal).
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Investigators will determine change in small bowel villi after withdrawal of budesonide compared to continued therapy to assess small intestinal injury. This will be accomplished by esophagogastroduodenoscopy (upper scope) with biopsies from the small intestine.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Symptoms (monitored daily) will be compared between patients that withdraw from budesonide compared to those that continue budesonide therapy. Symptoms will be measured on the Celiac Disease Symptom Diary (CDSD) questionnaire. First question asks if subject has diarrhea and how many times. Second question asks if subject has spontaneous bowel movement and how many. Third question asks if subject had abdominal pain and to rate on a scale from 0 to 10 with higher numbers being worse pain. Fourth question asks if experiencing bloating and if it is very mild, mild, moderate, severe, or very severe. Fifth question asks if subject has nausea and if it is ranked very mild, mild, moderate, severe, or very severe. The sixth question asks if the subject has experienced tiredness and to rank very mild, mild, moderate, severe or very severe. Each question is evaluated for changes or trends over time, and a composite score including multiple questions can be calculated and compared.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Quality of life will be assessed monthly comparing those that withdraw from budesonide compared to those that continue therapy. This will be assessed by the Celiac Disease Quality of Life Questionnaire (CD-QOL). This survey includes 20 questions with scores for each ranging from 1 to 5, with higher numbers indicating improved quality of life. Total scores will range from 20 to 100 with higher numbers indicating better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Weight in kilograms will be monitored throughout the study. Changes will be compare between those withdrawing from budesonide compared to those continuing therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Iron in the blood will be compared to those that withdraw from budesonide compared to those that continue therapy. This will be assessed at the initiation and completion of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
25-hydroxy vitamin D in the blood will be compared to those that withdraw from budesonide compared to those that continue therapy. This will be assessed at the initiation and completion of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Vitamin B12 in the blood will be compared to those that withdraw from budesonide compared to those that continue therapy. This will be assessed at the initiation and completion of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Folate in the blood will be compared to those that withdraw from budesonide compared to those that continue therapy. This will be assessed at the initiation and completion of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Zinc in the blood will be compared to those that withdraw from budesonide compared to those that continue therapy. This will be assessed at the initiation and completion of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Study was terminated due to recruitment being difficult and not achieved. Data was not collected nor analyzed.
Copper in the blood will be compared to those that withdraw from budesonide compared to those that continue therapy. This will be assessed at the initiation and completion of the trial.
Outcome measures
Outcome data not reported
Adverse Events
Continued Budesonide
Withdrawal of Budesonide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continued Budesonide
Patients in this arm continued budesonide at the dose they were taking at the time of enrollment in the trial
|
Withdrawal of Budesonide
n=1 participants at risk
Patients were weaned off of budesonide over 2 weeks and continued off of the medication for the duration of the trial
Withdrawal of Oral Budesonide: The intervention arm tapered and stoped budesonide therapy (withdrawal).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • Adverse Events were collected from baseline to end of study, approximately 2 weeks
Study was terminated due to recruitment being difficult and not achieved. There was no accrual in the Continued Budesonide arm
|
100.0%
1/1 • Adverse Events were collected from baseline to end of study, approximately 2 weeks
Study was terminated due to recruitment being difficult and not achieved. There was no accrual in the Continued Budesonide arm
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place