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Celiac Disease Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01902368
Recruitment Status : Terminated (No funding was obtained.)
First Posted : July 18, 2013
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Leffler, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE July 15, 2013
First Posted Date  ICMJE July 18, 2013
Last Update Posted Date March 19, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
change in health related quality of life [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
as measured by the EQ-5D
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celiac Disease Screening
Official Title  ICMJE A Prospective Trial of Celiac Disease Screening
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:

  1. 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.
  2. Treatment does not lead to adverse metabolic changes.
  3. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Celiac Disease
Intervention  ICMJE Other: gluten free diet
Study Arms  ICMJE
  • screen detected, early diagnosis cohort
    Subjects will be informed they have celiac disease and will be started on the gluten free diet.
    Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 28, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2013)
2000
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01902368
Other Study ID Numbers  ICMJE 2012P000326
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Leffler, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Leffler, MD, MS Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP