Celiac Disease Screening

A Prospective Trial of Celiac Disease Screening

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.

Study Overview

• Status: Terminated
• Conditions: Celiac Disease
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in health related quality of life	as measured by the EQ-5D	Baseline, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in celiac symptoms	as measured by the Celiac Symptom Index	Baseline, 3, 6, 9 and 12 months
change in bone density	as measured by dual energy x-ray absorptiometry	Baseline and 12 months
change in psychological well-being	as measured by the Psychological General Well-Being Index	Baseline, 3, 6, 9, and 12 months
change in burden of treatment	as measured by the disease burden visual analog scale	baseline, 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Daniel Leffler, MD, MS, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 18, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Gluten free diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 2012P000326