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Principal Investigator: Benjamin Lebwohl
Organization: COLUMBIA UNIVERSITY HEALTH SCIENCES
Fiscal Year: 2024
Award: $1,333,964
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
PROJECT SUMMARY
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 food (e.g., portable gluten
sensors) and 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 these technologies 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 technologies. 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.
Terms: <21+ years old><7S Gamma Globulin><Active Follow-up><Address><Adherence><Adoption><Adult><Adult Human><Affect><Anemia><Anti-TG2><Anti-tTG><Antibodies><Antibodies to tissue transglutaminase><Antitissue transglutaminase antibodies><Anxiety><Autoantibodies><Autoantibodies to tissue transglutaminase><Awareness><Behavioral><Blood Serum><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 antigen><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Cancers><Cannot achieve a pregnancy><Celiac Disease><Celiac Sprue><Chemistry><Clinical><Clinical Management><Clinical Trials><Coeliac Disease><Communication><Complement><Complement Proteins><Consumption><Country><Detection><Diagnosis><Dietitian><Difficulty conceiving><Digestive Diseases><Digestive System Diseases><Digestive System Disorders><Disease Management><Disorder Management><Eating Behavior><Effectiveness><Evaluation><Fatigue><Food><GI tract disorder><Gastroenterology><Gliadin><Glutelin><Gluten><Gluten Enteropathy><Gluten-Sensitive Enteropathy><Gluten-free diet><Grant><Health><Health Care Professional><Health Professional><Healthcare professional><Height><Histology><Home><IgA><IgG><Illinois><Immune Diseases><Immune Disorders><Immune Dysfunction><Immune System Diseases><Immune System Disorder><Immune System Dysfunction><Immune System and Related Disorders><Immunodeficiency and Immunosuppression Disorders><Immunoglobulin A><Immunoglobulin G><Immunologic Diseases><Immunological Diseases><Immunological Dysfunction><Immunological System Dysfunction><Incidence><Individual><Infertility><Infrastructure><Intervention><Intervention Strategies><Lack of Energy><Link><Lymphocyte Count><Lymphocyte Number><Malignant Neoplasms><Malignant Tumor><Massachusetts><Measures><Mediator><Mental Depression><Monitor><Morbidity><Morbidity - disease rate><Motivation><Mucosa><Mucosal Tissue><Mucous Membrane><NIDDK><National Institute of Diabetes and Digestive and Kidney Diseases><New York><Newly Diagnosed><Non-tropical Sprue><Nontropical Sprue><Osteoporosis><Outcome><Outcome Study><Participant><Pathway interactions><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Peptide antibodies><Peptides><Performance><Persons><Physicians><Pisum sativum><Population><QOL><Quality of life><Randomized><Randomized, Controlled Trials><Recommendation><Recovery><Regimen><SARS-CoV-2 antigen><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Sample Size><Sampling><Serology><Seroprevalences><Serum><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Social support><Symptoms><Technology><Telemedicine><Tennessee><Testing><Tissue Transglutaminase Antibodies><Tissue transglutaminase IgA><Tissue transglutaminase autoantibodies><Total Lymphocyte Count><Translating><United States><Urine><Videoconferencing><Villus><acceptability and feasibility><active followup><adulthood><antigen based test><antigen test><assess effectiveness><autoimmune antibody><autoreactive antibody><clinical development><comparative cost effectiveness><compare cost><compare cost effectiveness><complementation><coronavirus disease 2019 antigen><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><cost comparison><cost effective><cost effectiveness><deamidation><depression><determine effectiveness><diet adherence><dietary><dietary adherence><digestive disorder><digestive tract disease><effectiveness assessment><effectiveness evaluation><effectiveness testing><evaluate effectiveness><examine effectiveness><fertility cessation><fertility loss><follow up><follow-up><followed up><followup><gastrointestinal symptom><gastrointestinal tract disease><gastrointestinal tract disorder><homes><idiopathic steatorrhea><immunogenic><improved><infertile><interventional strategy><intraepithelial><malignancy><meeting><meetings><mortality><neoplasm/cancer><new technology><novel><novel technologies><pandemic><pandemic disease><pathway><patient oriented outcomes><pea><portability><primary end point><primary endpoint><primary outcome><psychologic><psychological><randomisation><randomization><randomized control trial><randomly assigned><rapid testing><recruit><secondary outcome><self reactive antibody><sensor><severe acute respiratory syndrome coronavirus 2 antigen><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><social><social support network><standard of care><tool><validation studies><video conferencing>