Telemedicine + Gluten Detection Tech for Celiac Disease

(GLUTECH Trial)

Recruiting at 3 trial locations

Overseen By Benjamin Lebwohl, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pregnancy, Not gluten-free diet, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people manage celiac disease. It combines regular telemedicine check-ins with a dietitian and new gluten detection technology to assess improvements in recovery and long-term health. The trial aims to reduce the physical and psychological challenges of celiac disease. It seeks adults diagnosed with celiac disease in the last four months who are willing to use the gluten detection technology. Participants should have already visited a dietitian at one of the participating centers. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative approaches in managing celiac disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are in another clinical trial for an experimental drug.

What prior data suggests that these technologies are safe for managing celiac disease?

Research shows that gluten detection technology is being tested for safety and effectiveness. In earlier studies, a portable gluten sensor identified gluten in food with 90% accuracy when levels exceeded 20 mg/kg. This device can help people with celiac disease avoid gluten.

Researchers have observed the technology over long periods in various trials to ensure its safety in detecting gluten. Although this is one of the first large studies of its kind, no major side effects have been reported, suggesting the device is safe to use.

Telemedicine, which involves remote health monitoring through online communication, is already widely used and considered safe. Combining telemedicine with gluten detection technology appears to be a safe way to manage celiac disease. However, since this combination is new, ongoing trials are needed to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for celiac disease because it explores the potential of combining continuous telemedicine monitoring with advanced gluten detection technology. Unlike the standard care, which typically involves regular check-ins with a dietitian, this approach leverages technology to provide real-time support and guidance. The gluten detection tech allows individuals to identify hidden gluten in their food, offering a proactive way to manage their diet. This could lead to better control over symptoms and improve quality of life for those with celiac disease.

What evidence suggests that this trial's treatments could be effective for managing celiac disease?

Research has shown that gluten detection technology can help people with celiac disease manage their gluten-free diet more effectively. One study found that a portable gluten sensor detected harmful gluten levels 90% of the time, helping users avoid foods that might harm their intestines. The sensor is quick and easy to use, providing results in about three minutes. In this trial, some participants will receive standard care with continuous telemedicine monitoring, while others will receive the same care plus gluten detection technology. By helping people avoid gluten, this technology may support gut healing and reduce symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin Lebwohl, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

Adults aged 18-75, recently diagnosed with celiac disease, who are willing to use gluten-detection technology and have had an initial dietitian visit at a participating center. They must not be pregnant or planning pregnancy during the study nor involved in another drug trial.

Inclusion Criteria

I have been diagnosed with celiac disease through blood tests and a biopsy showing specific changes in my intestine.

Willingness to use gluten-detection technology

Having already had an initial dietitian visit at one of the participating celiac disease centers

Exclusion Criteria

Not planning to follow a gluten-free diet

Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition)

Currently pregnant or planning to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' gastrointestinal symptoms, diet adherence, quality of life, and other baseline measures

1 week

Treatment

Participants receive either standard of care or standard of care plus gluten detection technology

12 months

Continuous telehealth follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mucosal recovery and symptom assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous telemedicine monitoring
• Continuous telemedicine monitoring plus gluten detection technology

Trial Overview The effectiveness of using gluten detection technologies alongside telemedicine for managing celiac disease is being tested. This randomized controlled trial aims to see if this approach helps patients recover better and cope with the condition's challenges.

How Is the Trial Designed?

Group I: Standard of Care Plus Technology Experimental Treatment 2 Interventions

In addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet.

Group II: Standard of Care Active Control 1 Intervention

Participants will be provided with continuous Telehealth dietitian follow-up

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The Nima™ gluten sensor is a portable device that accurately detects gluten proteins at levels below the safe threshold of 20 ppm, making it a valuable tool for individuals with celiac disease to ensure food safety.

With a 99.0% true positive rate in detecting gluten, the Nima™ device demonstrates high sensitivity and reliability, significantly improving the ability of gluten-sensitive individuals to manage their dietary restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated, accurate, rapid, and economical handheld consumer gluten detector. Zhang, J., Portela, SB., Horrell, JB., et al.[2019]

Testing cream cheese and similar dairy products for gluten using the NIMA sensor can lead to false positive results, particularly influenced by the weight and viscosity of the sample tested.

In controlled tests, all dairy materials were found to have gluten levels below the detection limit using standard ELISA methods, indicating that the NIMA sensor's results may not be reliable without careful consideration of sample preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer-Led Investigation into Potential Issues That Arise When Testing Dairy Matrixes for Gluten With the NIMA Sensor. Thompson, T., Rogers, A., Perry, J.[2023]

Celiac disease is a growing autoimmune disorder that primarily affects the small intestine and requires lifelong adherence to a gluten-free diet for management.

Biosensors represent a promising advancement in the detection of celiac disease biomarkers, offering a non-invasive, rapid, and cost-effective method for diagnosis and monitoring, which could improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosensors for Non-Invasive Detection of Celiac Disease Biomarkers in Body Fluids. Pasinszki, T., Krebsz, M.[2018]

In a study of 13 patients with chronic diarrhea after gluten intake, 9 were diagnosed with celiac disease (CD) based on positive serological tests and intestinal biopsies, highlighting the importance of these tests for accurate diagnosis.

A gluten-free diet was effective for 12 out of 13 patients, demonstrating that strict adherence to this diet is crucial for managing CD and preventing symptoms, which can include increased bowel movements upon gluten re-exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical analysis of gluten-related disease]. Diao, M., Bao, J., Xu, Y.[2018]

Telemedicine was effectively used for monitoring celiac disease patients during the COVID-19 pandemic, with a high completion rate of 92.9% for scheduled televisits among symptomatic patients.

Patients showed strong trust in the telemedicine service, with over 94% expressing confidence in the system, and gluten detection tests were successfully utilized to confirm adherence to the gluten-free diet remotely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional and Gastroenterological Monitoring of Patients With Celiac Disease During COVID-19 Pandemic: The Emerging Role of Telemedicine and Point-of-Care Gluten Detection Tests. Costantino, A., Roncoroni, L., Noviello, D., et al.[2021]

Celiac disease, wheat sensitivity, and allergy affect about 7% of the global population, and the only effective treatment is a strict gluten-free diet, which is challenging due to the risk of gluten contamination in supposedly 'gluten-free' products.

Recent advancements in gluten detection methods, particularly those that identify immunogenic gluten peptides without antibodies, could significantly improve food safety for celiac patients by ensuring lower contamination levels in both raw and processed foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten Detection Methods and Their Critical Role in Assuring Safe Diets for Celiac Patients. Osorio, CE., Mejías, JH., Rustgi, S.[2020]

In a 3-month pilot study involving 30 participants with biopsy-confirmed coeliac disease, users of a portable gluten sensor reported increased assurance and control over their gluten-free diet, highlighting its potential as a helpful tool for managing coeliac disease.

However, participants also expressed concerns about the sensor's accuracy, physical difficulty in use, and social discomfort, indicating that while the sensor offers benefits, improvements are needed for user experience and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable gluten sensors: qualitative assessments by adults and adolescents with coeliac disease. Wolf, RL., Vipperman-Cohen, A., Green, PHR., et al.[2021]

A study analyzing 5,624 tests from a portable gluten detection device found that 32% of gluten-free labeled restaurant foods contained detectable gluten, highlighting a significant risk for individuals with celiac disease.

Gluten contamination was particularly high in gluten-free labeled pizza and pasta, with detection rates of 53.2% and 50.8%, respectively, suggesting that these foods should be approached with caution by those adhering to a gluten-free diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Gluten in Gluten-Free Labeled Restaurant Food: Analysis of Crowd-Sourced Data. Lerner, BA., Phan Vo, LT., Yates, S., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06059716?cond=digestive%20disease&spons=NIDDK&aggFilters=status:not%20rec%20act&viewType=Table&rank=10

Gluten Technology and Education for Celiac Health 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8329040/

A Portable Gluten Sensor for Celiac Disease Patients May ... The detection rate for samples containing ≥20 mg/kg of gluten was 90%. Samples containing 2 mg/kg of gluten or below consistently tested negative, but samples ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06059716/gluten-technology-and-education-for-celiac-health

Gluten Technology and Education for Celiac Health ... gluten detection technology in the management of celiac disease. The primary outcome will be mucosal recovery 12-months post-randomization.

4. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/ncp.11324

Use of technology to educate patients with celiac disease The Nima sensor is based on lateral flow immunoassay technology to rapidly detect gluten. Data on the reliability and practicality of the Nima ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03321214

Study Details | NCT03321214 | Gluten Sensor Device to ... Nima is a small portable sensor that detects gluten in a small amount of liquid and solid foods in about three minutes. Nima combines an electronic sensor with ...

6. trialx.com trialx.com/5-ongoing-breakthrough-clinical-trials-advancing-celiac-disease-research/

5 Ongoing Breakthrough Clinical Trials Advancing Celiac ... The study will monitor participants for up to 86 weeks to evaluate both safety and the therapy's effectiveness during controlled gluten exposure ...

7. beyondceliac.org beyondceliac.org/research-news/promising-new-test-may-eliminate-the-need-to-be-eating-gluten-to-get-diagnosed-with-celiac-disease/

Promising new test may eliminate the need to be eating ... Results showed the test was 90 percent accurate in detecting which study participants, including those who were not eating gluten, had celiac ...