Celiac Disease Screening
Primary Purpose
Celiac Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gluten free diet
Sponsored by
About this trial
This is an interventional screening trial for Celiac Disease focused on measuring Gluten free diet
Eligibility Criteria
Inclusion Criteria:
- Be ambulatory, community dwelling, 18 to 80 years, inclusive
For the screening cohort:
- Have a first or second degree family member with known biopsy-proven celiac disease.
- Have not been on a gluten-free diet in the past 6 months
- Have not received a prior diagnosis of celiac disease at any time
For the clinically detected cohort
- Have biopsy proven celiac disease detected based on clinical symptoms and on a gluten free diet for less than 1 month.
Exclusion Criteria:
- For the screen detected cohort, have significantly severe symptoms (as judged by the investigator) at screening which preclude randomization;
- Be on a gluten-free diet or have been on a gluten-free diet within the past 6 months.
- Be pregnant or planning pregnancy in the study time period
- Be taking corticosteroids or immunomodulators
- Have a history of significant concomitant gastrointestinal disease or other comorbidity judged by the investigator to potentially interfere with study outcomes
- Be unable or unwilling to cooperate with the study protocol
- Have insufficient knowledge of English to complete study surveys
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
screen detected, early diagnosis cohort
screen detected, delayed diagnosis cohort
Arm Description
Subjects will be informed they have celiac disease and will be started on the gluten free diet.
Subjects will not be told they have celiac disease and will not start the gluten free diet.
Outcomes
Primary Outcome Measures
change in health related quality of life
as measured by the EQ-5D
Secondary Outcome Measures
change in celiac symptoms
as measured by the Celiac Symptom Index
change in bone density
as measured by dual energy x-ray absorptiometry
change in psychological well-being
as measured by the Psychological General Well-Being Index
change in burden of treatment
as measured by the disease burden visual analog scale
Full Information
NCT ID
NCT01902368
First Posted
July 15, 2013
Last Updated
March 16, 2018
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01902368
Brief Title
Celiac Disease Screening
Official Title
A Prospective Trial of Celiac Disease Screening
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
No funding was obtained.
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if it makes sense to test people for celiac disease who have a first or second degree relative (parent, sibling, child, grandparent, aunt or uncle) with celiac disease. The investigators will check to see what differences there are in the health and quality of life between those who know they have celiac disease and start the gluten free diet and those who do not.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Gluten free diet
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
screen detected, early diagnosis cohort
Arm Type
Other
Arm Description
Subjects will be informed they have celiac disease and will be started on the gluten free diet.
Arm Title
screen detected, delayed diagnosis cohort
Arm Type
No Intervention
Arm Description
Subjects will not be told they have celiac disease and will not start the gluten free diet.
Intervention Type
Other
Intervention Name(s)
gluten free diet
Primary Outcome Measure Information:
Title
change in health related quality of life
Description
as measured by the EQ-5D
Time Frame
Baseline, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
change in celiac symptoms
Description
as measured by the Celiac Symptom Index
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
change in bone density
Description
as measured by dual energy x-ray absorptiometry
Time Frame
Baseline and 12 months
Title
change in psychological well-being
Description
as measured by the Psychological General Well-Being Index
Time Frame
Baseline, 3, 6, 9, and 12 months
Title
change in burden of treatment
Description
as measured by the disease burden visual analog scale
Time Frame
baseline, 3, 6, 9, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be ambulatory, community dwelling, 18 to 80 years, inclusive
For the screening cohort:
Have a first or second degree family member with known biopsy-proven celiac disease.
Have not been on a gluten-free diet in the past 6 months
Have not received a prior diagnosis of celiac disease at any time
For the clinically detected cohort
Have biopsy proven celiac disease detected based on clinical symptoms and on a gluten free diet for less than 1 month.
Exclusion Criteria:
For the screen detected cohort, have significantly severe symptoms (as judged by the investigator) at screening which preclude randomization;
Be on a gluten-free diet or have been on a gluten-free diet within the past 6 months.
Be pregnant or planning pregnancy in the study time period
Be taking corticosteroids or immunomodulators
Have a history of significant concomitant gastrointestinal disease or other comorbidity judged by the investigator to potentially interfere with study outcomes
Be unable or unwilling to cooperate with the study protocol
Have insufficient knowledge of English to complete study surveys
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Leffler, MD, MS
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Celiac Disease Screening
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