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Celiac Disease Screening

This study has been terminated.
(No funding was obtained.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01902368
First Posted: July 18, 2013
Last Update Posted: March 27, 2017
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.
Information provided by (Responsible Party):
Daniel Leffler, Beth Israel Deaconess Medical Center
  Purpose
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.

Condition Intervention
Celiac Disease Other: gluten free diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: A Prospective Trial of Celiac Disease Screening

Resource links provided by NLM:


Further study details as provided by Daniel Leffler, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • change in health related quality of life [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    as measured by the EQ-5D


Secondary Outcome Measures:
  • 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


Enrollment: 14
Study Start Date: September 2013
Study Completion Date: August 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Daniel Leffler, MD, MS Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Daniel Leffler, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01902368     History of Changes
Other Study ID Numbers: 2012P000326
First Submitted: July 15, 2013
First Posted: July 18, 2013
Last Update Posted: March 27, 2017
Last Verified: March 2017

Keywords provided by Daniel Leffler, Beth Israel Deaconess Medical Center:
Gluten free diet

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases