Celiac DiseaseNCT01902368
Celiac Disease Screening
A study testing gluten free diet in people with Celiac Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- gluten free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- gluten free diet
- Keywords
- Gluten free diet
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluten free dietOther
| Study group | Role | What they receive |
|---|---|---|
| screen detected, early diagnosis cohort | Other | Subjects will be informed they have celiac disease and will be started on the gluten free diet. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in health related quality of life
as measured by the EQ-5D
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (4)
change in celiac symptoms
as measured by the Celiac Symptom Index
Measured: Baseline, 3, 6, 9 and 12 months
change in bone density
as measured by dual energy x-ray absorptiometry
Measured: Baseline and 12 months
change in psychological well-being
as measured by the Psychological General Well-Being Index
Measured: Baseline, 3, 6, 9, and 12 months
change in burden of treatment
as measured by the disease burden visual analog scale
Measured: baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionAug 2014
Why it stopped: No funding was obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Leffler, Beth Israel Deaconess Medical Center
- Investigators
- Daniel Leffler, MD, MS, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902368
- Sponsor's protocol ID
- 2012P000326
- Status last verified
- Mar 2018
- First submitted
- 15 Jul 2013
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Celiac Disease Screening
- ClinicalTrials.gov ID
- NCT01902368
- Acronym / sponsor ID
- 2012P000326
- Conditions
- Celiac Disease
- Keywords
- Gluten free diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding was obtained.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screen detected, early diagnosis cohort | Other | Other: gluten free dietSubjects will be informed they have celiac disease and will be started on the 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be ambulatory, community dwelling, 18 to 80 years, inclusive
- For the screening cohort:
- For the clinically detected cohort
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gluten free diet | Other | screen detected, early diagnosis cohort |
Primary outcome
change in health related quality of life
Time frame: Baseline, 3, 6, 9 and 12 months
as measured by the EQ-5D
4 secondary outcomes
change in celiac symptoms
Time frame: Baseline, 3, 6, 9 and 12 months
change in bone density
Time frame: Baseline and 12 months
change in psychological well-being
Time frame: Baseline, 3, 6, 9, and 12 months
change in burden of treatment
Time frame: baseline, 3, 6, 9, and 12 months
Results and safety
The study was stopped early (reason given: No funding was obtained.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
Related trials for Celiac Disease
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingObservational study
European Appleby Registry for Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Leffler, MD, MS principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten free diet in people with Celiac Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding was obtained.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in health related quality of life (time frame: Baseline, 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.