Celiac DiseaseGLUTECHNCT06059716
Gluten Technology and Education for Celiac Health
A study testing Gluten detection technology and Continuous telemedicine monitoring in people with Celiac Disease, run by Columbia University at 4 sites in United States.
Trial summary
The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Gluten detection technology and Continuous telemedicine monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Oct 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender; Age 18-75 years
- Celiac disease diagnosis by serology and duodenal biopsy (corresponding to •Marsh 3 histology), adequate sampling and interpretable villus height to crypt depth ratio upon review by our study pathologist
- Diagnosed with celiac disease within 4 months of initial study screening
- Willingness to use gluten-detection technology
- Not currently using a gluten detection technology that tests for gluten in urine or stool
Who cannot join
- Currently pregnant or planning to become pregnant during the study
- Not planning to follow a gluten-free diet
- Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Randi Wolf, PhD, MPH contact
United States4 sites, 4 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jocelyn Silvester, MD, PhD
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Sonia Kupfer, MD, 773-834-1438
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Dawn Adams, MD, 615-936-0192
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
About this study
The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.
Read the detailed description
The proposed project addresses the need for a rigorous trial to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in adults. Celiac disease affects about 1% of the United States (U.S.) population and seroprevalence has increased up to 5-fold in the U.S. since the 1950's, with diagnosis rates continuing to rise. Morbidity can be severe and includes anemia, infertility, osteoporosis, and malignancies, which can increase all-cause mortality. The only proven therapy is a strict gluten-free diet, the management of which can be extremely challenging and has been linked to diminished quality of life, including anxiety, depression, and fatigue. Despite the recommendation to see a dietitian regularly, many with celiac disease do not see one at all or have only a single session immediately post-diagnosis. The COVID-19 pandemic has catalyzed the rapid adoption of telemedicine in gastroenterology and can facilitate communication between patient and dietitian by eliminating the need to arrange face-to-face meetings at celiac disease centers, which may be at great distance. Self-monitoring with new technologies for gluten detection in urine (e.g., gluten immunogenic peptide kits) can facilitate greater individual awareness of gluten exposures, are commercially available to the public, and have been shown to be valid and reliable. Physicians and dietitians are being asked if this technology should be used, and our preliminary studies have demonstrated acceptability and feasibility, but their impact on clinical outcomes such as mucosal recovery and symptoms has not been established. This U01 proposal is for a multi-center (New York, Massachusetts, Illinois, Tennessee) randomized controlled trial (M-RCT) to assess the effectiveness and document costs of gluten detection technologies as an adjunct to telemedicine on behavioral and clinical outcomes among newly diagnosed patients with celiac disease. Participants will be randomized to receive either 1) standard of care (i.e. a one-time in-person dietitian session plus telemedicine dietitian follow-up; or 2) standard of care + gluten detection technology. This would be the first large-scale clinical trial to test the effect of self-monitoring using gluten detection technology in the management of celiac disease. The primary outcome will be mucosal recovery 12-months post-randomization. Secondary outcomes include change in gastrointestinal symptoms, diet adherence, quality of life (including anxiety and depression), eating behaviors, intraepithelial lymphocyte counts on histology, and celiac disease serology, all assessed at baseline and again at 12-months post-randomization. If the primary endpoint of this proposed U01 is met, the intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.
- Conditions
- Celiac Disease
- Being tested
- Gluten detection technology, Continuous telemedicine monitoring
- 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 detection technologyBehavioural
Also called Gluten Detect
Portable technology to sense gluten after ingestion
Continuous telemedicine monitoringBehavioural
Regular follow-up with an expert dietitian
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants will be provided with continuous Telehealth dietitian follow-up Receives: Behavioral: Continuous telemedicine monitoring |
| Standard of Care Plus Technology | Experimental | In addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet. Receives: Behavioral: Gluten detection technology; Behavioral: Continuous telemedicine monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small Intestinal Healing
This will be measured with a measure in villus height to crypt depth ratio on small intestinal biopsy.
Measured: 12 months
Secondary outcomes (10)
Score on the Celiac Dietary Adherence Test (CDAT)
Gastrointestinal symptoms will be measured using a validated instrument, the CDAT, which is used to assess adherence to a gluten-free diet (GFD). The questionnaire consists of 7 items on a 5-point Likert scale, and the sum of the numeric values assigned to the answers provides a score ranging from 7 to 35 points, with a lower score indicating excellent GFD adherence (better outcome).
Measured: 12 months
Score on the Celiac Disease Symptom Diary (CDSD)
Celiac disease symptoms will be measured with a validated 5-item score measuring intestinal and extra-intestinal symptoms. Each question is scored to calculate a composite score, which can range from 0 (min) to 20 (max), with 0 indicating least severe (better outcome) and 20 indicating most severe.
Measured: 12 months
Score on the Celiac-Disease specific Quality of Life (CDQOL)
CD-QOL is a self-administered questionnaire, which has 20 items across four clinically relevant subscales that are to be answered using a Likert scale. The overall score is expressed on a scale of 0-100, with a higher score suggesting a better quality of life and better outcome (a poor score is less than or equal to a score of 40, and a good overall score is greater than or equal to a score of 60).
Measured: 12 months
Score on PROMIS 29+2
The The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is used to calculate a preference score. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). The profile includes all items in the PROMIS-29 plus two Cognitive Function Abilities items. Scores are calculated using a table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Scores can range from 31 (min) to 155 (max), and a higher score indicates a better outcome.
Measured: 12 months
Score on the State-Trait Anxiety Inventory (STAI)
Anxiety will be measured using the STAI, which is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety (worse outcome).
Measured: 12 months
Score on the Center for Epidemiologic Studies Depression Scale for adults (CESD-R)
Depression will be measured using a 20-item validated survey instrument, the Center for Epidemiologic Studies Depression Scale (CESD-R). This scale is a self-report measure of depression. The questions measure 8 different subscales, including: sadness (dysphoria), loss of interest (anhedonia), appetite, sleep, thinking/concentration, guilt (worthlessness), tired (fatigue), movement (agitation), suicidal ideation. The response values for each question range from 0 (Not at all or less than one day) to 4 (Nearly every day for 2 weeks) The total score is calculated by finding the sum of 20 items. Scores range from 0-60 with a higher score indicating a worse outcome. A score equal to or above 16 indicates a person at risk for clinical depression.
Measured: 12 months
Score on the CD-FAB
Eating patterns and behaviors will be measured with the Celiac Disease Food Attitudes and Behaviors (CD-FAB). The CD-FAB is an 11-item self-reported, validated tool that investigates the eating attitudes and behaviors resulting from beliefs concerning cross-contamination, trust, risk-taking, and food safety. Items are based on a 7-point Likert scale and total scores range from 11 to 77, with a higher score suggesting more maladaptive eating attitudes and behaviors (worse outcome).
Measured: 12 months
Intraepithelial Lymphocyte Count (ILC)
Intraepithelial lymphocyte count will be assessed using standardized procedures (duodenal biopsy). Using a length of surface epithelium of an entire villus and/or the villous tip in formalin fixed, paraffin embedded, Hematoxylin and Eosin-stained biopsies under the light microscope. The results are expressed as lymphocytes per 100 epithelial cells.
Measured: 12 months
Tissue Transglutaminase IgA (TTG-IgA) Level
Serum Tissue Transglutaminase immunoglobulin A (IgA) will be measured using standardized immunoassays.
Measured: 12 months
DGP IgA/IgG Level
Serum Deamidated gliadin peptide (DGP) IgA/IgG will be measured using standardized immunoassays.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start8 Oct 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
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 Columbia UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Lebwohl, Columbia University
- Investigators
- Benjamin Lebwohl, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059716
- Sponsor's protocol ID
- AAAU4644
- Other IDs
- U01DK136523
- Acronym
- GLUTECH
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of the trial results, the steering committee may grant access to de-identified data to individuals upon request. This includes the statistical code, questionnaires, and technical processes. The corresponding author of the study will be responsible for conveying the request to the steering committee, communicating with the requestor, and facilitating the transfer of data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluten Technology and Education for Celiac Health
- ClinicalTrials.gov ID
- NCT06059716
- Acronym / sponsor ID
- GLUTECH / AAAU4644
- Conditions
- Celiac Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Sep 2023 (actual)
- 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 investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.
Detailed description
The proposed project addresses the need for a rigorous trial to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in adults. Celiac disease affects about 1% of the United States (U.S.) population and seroprevalence has increased up to 5-fold in the U.S. since the 1950's, with diagnosis rates continuing to rise. Morbidity can be severe and includes anemia, infertility, osteoporosis, and malignancies, which can increase all-cause mortality. The only proven therapy is a strict gluten-free diet, the management of which can be extremely challenging and has been linked to diminished quality of life, including anxiety, depression, and fatigue. Despite the recommendation to see a dietitian regularly, many with celiac disease do not see one at all or have only a single session immediately post-diagnosis. The COVID-19 pandemic has catalyzed the rapid adoption of telemedicine in gastroenterology and can facilitate communication between patient and dietitian by eliminating the need to arrange face-to-face meetings at celiac disease centers, which may be at great distance. Self-monitoring with new technologies for gluten detection in urine (e.g., gluten immunogenic peptide kits) can facilitate greater individual awareness of gluten exposures, are commercially available to the public, and have been shown to be valid and reliable. Physicians and dietitians are being asked if this technology should be used, and our preliminary studies have demonstrated acceptability and feasibility, but their impact on clinical outcomes such as mucosal recovery and symptoms has not been established. This U01 proposal is for a multi-center (New York, Massachusetts, Illinois, Tennessee) randomized controlled trial (M-RCT) to assess the effectiveness and document costs of gluten detection technologies as an adjunct to telemedicine on behavioral and clinical outcomes among newly diagnosed patients with celiac disease. Participants will be randomized to receive either 1) standard of care (i.e. a one-time in-person dietitian session plus telemedicine dietitian follow-up; or 2) standard of care + gluten detection technology. This would be the first large-scale clinical trial to test the effect of self-monitoring using gluten detection technology in the management of celiac disease. The primary outcome will be mucosal recovery 12-months post-randomization. Secondary outcomes include change in gastrointestinal symptoms, diet adherence, quality of life (including anxiety and depression), eating behaviors, intraepithelial lymphocyte counts on histology, and celiac disease serology, all assessed at baseline and again at 12-months post-randomization. If the primary endpoint of this proposed U01 is met, the intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Continuous telemedicine monitoringParticipants will be provided with continuous Telehealth dietitian follow-up |
| Standard of Care Plus Technology | Experimental | Behavioral: Gluten detection technology, Behavioral: Continuous telemedicine monitoringIn addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any gender; Age 18-75 years
- Celiac disease diagnosis by serology and duodenal biopsy (corresponding to •Marsh 3 histology), adequate sampling and interpretable villus height to crypt depth ratio upon review by our study pathologist
- Diagnosed with celiac disease within 4 months of initial study screening
- Willingness to use gluten-detection technology
- Not currently using a gluten detection technology that tests for gluten in urine or stool
Key exclusion criteria (3 listed)
- Currently pregnant or planning to become pregnant during the study
- Not planning to follow a gluten-free diet
- Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).
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 detection technologyAlso: Gluten DetectPortable technology to sense gluten after ingestion | Behavioural | Standard of Care Plus Technology |
| Continuous telemedicine monitoringRegular follow-up with an expert dietitian | Behavioural | Standard of Care, Standard of Care Plus Technology |
Primary outcome
Small Intestinal Healing
Time frame: 12 months
This will be measured with a measure in villus height to crypt depth ratio on small intestinal biopsy.
10 secondary outcomes
Score on the Celiac Dietary Adherence Test (CDAT)
Time frame: 12 months
Score on the Celiac Disease Symptom Diary (CDSD)
Time frame: 12 months
Score on the Celiac-Disease specific Quality of Life (CDQOL)
Time frame: 12 months
Score on PROMIS 29+2
Time frame: 12 months
Score on the State-Trait Anxiety Inventory (STAI)
Time frame: 12 months
Score on the Center for Epidemiologic Studies Depression Scale for adults (CESD-R)
Time frame: 12 months
Score on the CD-FAB
Time frame: 12 months
Intraepithelial Lymphocyte Count (ILC)
Time frame: 12 months
Tissue Transglutaminase IgA (TTG-IgA) Level
Time frame: 12 months
DGP IgA/IgG Level
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. Following publication of the trial results, the steering committee may grant access to de-identified data to individuals upon request. This includes the statistical code, questionnaires, and technical processes. The corresponding author of the study will be responsible for conveying the request to the steering committee, communicating with the requestor, and facilitating the transfer of data.
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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.
Randi Wolf, PhD, MPH contact
Benjamin Lebwohl, MD, MS principal investigator
Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten detection technology and Continuous telemedicine monitoring in people with Celiac Disease, run by Columbia University at 4 sites 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Lebwohl, MD, MS (212-305-9338, BL114@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small Intestinal Healing (time frame: 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 10 Jun 2026.