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17 Celiac Disease Trials near Miami, FL
Power is an online platform that helps thousands of Celiac Disease patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Amlitelimab for Celiac Disease
Miami Lakes, FloridaThis is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE).
The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo on gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied.
Study details include:
The study duration will be up to 48 weeks (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension.
The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension.
The double-blind placebo-controlled treatment duration will be up to 28 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Refractory Celiac, Inflammatory GI, Autoimmune, Others
Must Not Be Taking:NSAIDs, Immunosuppressants, Corticosteroids, Others
204 Participants Needed
TAK-101 for Celiac Disease
Miami Lakes, FloridaThis trial is testing a drug called TAK-101, given through an IV, to help adults with celiac disease who still have symptoms despite following a gluten-free diet. The drug aims to reduce these symptoms by changing how the immune system reacts to gluten. TAK-101 is designed to induce gluten-specific tolerance by encapsulating gluten protein in negatively charged nanoparticles. Participants will receive the drug at different times and doses to see how well it works and how safe it is.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Inflammatory Bowel Disease, Autoimmune Diseases, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
90 Participants Needed
KAN-101 for Celiac Disease
Hialeah Gardens, FloridaThe study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
55 Participants Needed
KAN-101 for Celiac Disease
Saint Petersburg, FloridaThis trial tests KAN-101, a new drug for adults with Celiac Disease on a gluten-free diet. Researchers are studying its safety, tolerance, and effects on the body and blood markers after gluten exposure.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:18 - 70
Sex:All
126 Participants Needed
VTP-1000 for Celiac Disease
St. Petersburg, FloridaGLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Refractory Celiac, IgA Deficiency, Others
45 Participants Needed
DONQ52 for Celiac Disease
Winter Park, FloridaThis trial is testing a new drug called DONQ52 in patients with well-managed celiac disease. The study has two parts: one where patients receive single doses and another where they receive multiple doses. The goal is to see if the drug is safe and well-tolerated.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
56 Participants Needed
TEV-53408 for Celiac Disease
Atlanta, GeorgiaThe primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.
The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease.
A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease.
The expected trial duration per participant is approximately 86 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 64
Sex:All
40 Participants Needed
Telemedicine + Gluten Detection Tech for Celiac Disease
Nashville, TennesseeThe 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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Not Gluten-free Diet, Others
200 Participants Needed
Behavioral Intervention for Celiac Disease
District of Columbia, District of ColumbiaCeliac disease (CD) is a chronic autoimmune condition whose only currently available treatment is a strict, burdensome gluten-free diet (GFD). The current proposal uses a theory-driven empirical approach for optimizing the GFD for teens and their parents by targeting knowledge, behavior, and coping skills through educational and cognitive-behavioral techniques. Integration with telehealth and SMS (short message service; "text") technology for delivering the intervention has the potential to reduce barriers to specialized treatment at both early and later stages of implementation. The proposed research will refine and test a behavioral intervention for teens with CD and their parents using an iterative stakeholder-centered design. It will consist of a small pilot randomized control trial (RCT) (n=96 dyads) that will examine the preliminary efficacy of the intervention and its impact on quality of life and GFD management by targeting self-efficacy, illness identity, and food-related activities. This work has the potential to make a lasting impact on the standards of care and available treatments to optimize CD management in youth and their families.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:12 - 16
Sex:All
96 Participants Needed
Gluten Challenge for Celiac Disease
Chicago, IllinoisThe purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Celiac, GI Disease, Others
Must Not Be Taking:Antibiotics, PPIs, NSAIDs, Others
220 Participants Needed
Timing of Gluten-free Oats Introduction for Celiac Disease
Hamilton, OntarioThe investigators are conducting a pilot study to investigate the impact of late compared to early introduction of gluten-free oats on gut symptoms, nutrition status, celiac activity and quality of life in patients with a recent diagnosis of celiac disease. Pilot study means that it will recruit a low number of participants to see if it is possible to perform the study, and to estimate how many participants will be needed for the large study. The study will collect information through questionnaires that assess gut symptoms, quality of life, mood changes and dietary patterns. Moreover, the study will collect data on tests done during clinic visits to check the status of patients' celiac markers and nutritional status (such as vitamins and minerals). Physical exam will also take place, and include measurement of weight, BMI and body composition in a 3D scanner. The dietitian will analyze patients' diet at each visit during the study period. Given the lack of evidence on timing of introduction of gluten-free oats for patients with a recent celiac diagnosis, and the potential risks of limiting oats in a gluten-free diet, the results will hopefully lead to better understanding of whether one strategy has a benefit over the other.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Removed Oats, Oats Allergy, Prior RD Education, Others
50 Participants Needed
Tryptophan for Celiac Disease
Hamilton, OntarioThis is a prospective, randomized, double-blind, placebo-controlled exploratory trial to evaluate the effect of L-tryptophan supplementation on celiac-related symptoms in individuals who have biopsy-confirmed celiac disease (CeD) and symptoms non-responsive to a gluten-free diet (GFD). Fifty participants, aged 18 to 75 years, who self-report persistent CeD-related symptoms despite taking a GFD for more than 1 year and who score \> 40 on the Celiac Symptom Index (CSI) will be randomized to receive L-tryptophan or placebo for 3 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, GI Diseases, Surgery, Others
Must Not Be Taking:Antacids, Antibiotics, MAOIs, Others
50 Participants Needed
Ritlecitinib for Celiac Disease
Boston, MassachusettsThis trial is testing Ritlecitinib to see if it can help adults with celiac disease in remission avoid symptoms when they eat gluten. Participants will take either the drug or a non-active substance and eat a small amount of gluten regularly. The drug aims to block immune signals that cause inflammation.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Gluten Triggered Symptoms, Inflammatory GI Disorder, TB, Others
Must Not Be Taking:Immunosuppressants
40 Participants Needed
Gluten Challenge for Celiac Disease
Boston, MassachusettsThis trial involves people with celiac disease and healthy individuals eating gluten powder to study their immune responses by measuring inflammation-related proteins in their blood.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:2+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Wheat Allergy, Type 1 Diabetes, Others
400 Participants Needed
OFDI Imaging for Duodenal Inspection
Boston, MassachusettsThe study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.
A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:16+
Sex:All
108 Participants Needed
Gluten-Free Diet Education for Celiac Disease
Boston, MassachusettsThe investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:2 - 18
Sex:All
120 Participants Needed
Gluten-Free Diet Guidance for Celiac Disease
Edmonton, AlbertaCeliac disease (CD) is an autoimmune gastrointestinal disease that is caused by intolerance to gluten in the diet. The mainstay of treatment is a gluten-free diet (GFD). Children with CD on the GFD often have low micronutrient intakes (e.g. folate, iron) and high intakes of sugar and fat. Current Canadian nutrition guideline does not address these nutritional limitations. The investigation team developed a novel GF-food guide (GFFG). This randomized clinical trial aims to evaluate the impact of GFFG on diet quality and adherence to the GFD in newly diagnosed children and youth with celiac disease in the clinical setting. The investigators will compare dietary counselling using the GFFG versus the standard of care in children newly diagnosed with CD and their parents to see if participant care outcomes (diet quality, nutrition literacy, adherence to the GFD) improved over six months.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:5 - 18
Sex:All
40 Participants Needed
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Frequently Asked Questions
How much do Celiac Disease clinical trials in Miami, FL pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Celiac Disease clinical trials in Miami, FL work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Celiac Disease trials in Miami, FL 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Miami, FL for Celiac Disease is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Miami, FL several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Celiac Disease medical study in Miami, FL ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Celiac Disease clinical trials in Miami, FL ?
Most recently, we added Gluten-Free Diet Education for Celiac Disease, TEV-53408 for Celiac Disease and Telemedicine + Gluten Detection Tech for Celiac Disease to the Power online platform.