Celiac Disease Screening

NCT01902368 | Terminated

• 1 other identifier: 2012P000326
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

Gluten free diet

Outcome Measures

Primary Outcomes (1)

• change in health related quality of life

  as measured by the EQ-5D

  Baseline, 3, 6, 9 and 12 months

Secondary Outcomes (4)

• change in celiac symptoms

  Baseline, 3, 6, 9 and 12 months

• change in bone density

  Baseline and 12 months

• change in psychological well-being

  Baseline, 3, 6, 9, and 12 months

• change in burden of treatment

  baseline, 3, 6, 9, and 12 months

Study Arms (2)

screen detected, early diagnosis cohort

OTHER

Subjects will be informed they have celiac disease and will be started on the gluten free diet.

Other: gluten free diet

screen detected, delayed diagnosis cohort

NO INTERVENTION

Subjects will not be told they have celiac disease and will not start the gluten free diet.

Interventions

gluten free diet OTHER

screen detected, early diagnosis cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Daniel Leffler, MD, MS

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

US (1)