Health TrialsbyHealthPanel

Gluten Technology and Education for Celiac Health

ConditionCeliac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Gluten detection technology

    Behavioral

    Portable technology to sense gluten after ingestion

  • Continuous telemedicine monitoring

    Behavioral

    Regular follow-up with an expert dietitian

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: Standard of Care Plus TechnologyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Small Intestinal Healing

This will be measured with a measure in villus height to crypt depth ratio on small intestinal biopsy.

Time frame
12 months

Secondary outcomes

1

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).

Time frame
12 months
2

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.

Time frame
12 months
3

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).

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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