Celiac Disease Screening
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|ClinicalTrials.gov Identifier: NCT01902368|
Recruitment Status : Terminated (No funding was obtained.)
First Posted : July 18, 2013
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease||Other: gluten free diet||Not Applicable|
Our overall hypothesis is that first and second degree relatives of individuals with celiac disease benefit from screening and diagnosis of celiac disease. Secondary hypotheses are:
- The number needed to test and cost to benefit one person though celiac disease screening are within acceptable ranges of 33 tested and < $10,000 spent.
- Treatment does not lead to adverse metabolic changes.
- Intestinal biopsy is unnecessary for accurate diagnosis in a substantial subset of adults.
Aim 1. Determine the effect of screen detected celiac disease on health related quality of life.
- Evaluate change in health related quality of life at one year in participants randomized to the screen detected, early diagnosis cohort compared to the screen detected, delayed diagnosis, clinically detected and non-celiac control cohorts.
- Evaluate change in symptoms, psychological well-being and burden of treatment at one year in the screen detected, early diagnosis cohort compared to the screen detected, delayed diagnosis, clinically detected and non-celiac control cohorts.
- Evaluate the cost per diagnosis and the number needed to test for the diagnosis of individuals who will have a clinically meaningful improvement in health related quality of life attributable to treatment of celiac disease.
Aim 2: Assess the effect of screen detected celiac disease on nutritional and metabolic indices.
- Compare changes bone density, body mass index, Reynolds Cardiovascular Risk Score, and nutritional indices at one year in the screen detected, early diagnosis cohort compared to the screen detected, delayed diagnosis, clinically detected and non-celiac control cohorts.
Aim 3: Evaluate the reliability of using serologic tests in combination with intestinal fatty acid binding protein vs. intestinal biopsy to confirm celiac disease diagnosis in adults.
- Prospectively assess the sensitivity and specificity of a novel non-invasive celiac diagnostic algorithm in comparison to the current gold standard of small intestinal biopsy histology.
- Model the cost of modified, non-invasive celiac testing vs. classical testing with endoscopic biopsy in both screen-detected and clinically identified celiac disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Trial of Celiac Disease Screening|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||August 2014|
screen detected, early diagnosis cohort
Subjects will be informed they have celiac disease and will be started on the gluten free diet.
Other: gluten free diet
No Intervention: screen detected, delayed diagnosis cohort
Subjects will not be told they have celiac disease and will not start the gluten free diet.
- change in health related quality of life [ Time Frame: Baseline, 3, 6, 9 and 12 months ]as measured by the EQ-5D
- change in celiac symptoms [ Time Frame: Baseline, 3, 6, 9 and 12 months ]as measured by the Celiac Symptom Index
- change in bone density [ Time Frame: Baseline and 12 months ]as measured by dual energy x-ray absorptiometry
- change in psychological well-being [ Time Frame: Baseline, 3, 6, 9, and 12 months ]as measured by the Psychological General Well-Being Index
- change in burden of treatment [ Time Frame: baseline, 3, 6, 9, and 12 months ]as measured by the disease burden visual analog scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902368
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Daniel Leffler, MD, MS||Beth Israel Deaconess Medical Center|