2 out of 3 people with celiac disease are regularly exposed to gluten

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Help advance scientific research by joining the CeliacShield Study

About the Study

Welcome to the CeliacShield Study website. This NIH-funded clinical research study has been designed to assess the investigational medication latiglutenase and its ability to relieve symptoms and protect the small intestine of celiac disease patients from gluten exposure. Latiglutenase consists of a combination of two enzymes which efficiently degrade gluten in the stomach when taken during meals.

 

As a study participant, you will be required to attend five in-person visits at the study site in Rochester, Minnesota over the course of 14 weeks. In addition, you will be asked to complete a daily electronic symptoms diary. You will be given gluten in the form of breadcrumbs (approximately one-half slice of bread) along with either the investigational medication or placebo at your evening meal for six consecutive weeks. The placebo resembles the investigational medication, but does not contain the active ingredients.

 

Participants will receive all study supplies, including the investigational medication as well as all study-related tests and procedures at no cost. Qualified participants may be reimbursed for study participation, including transportation costs. Please help advance a therapy for celiac patients by clicking the “See If You Pre-Qualify” button to learn more. Should you pre-qualify for the study, a study staff member will contact you and share additional study details as well as answer any of your questions.

For further information, refer to our study page on ClinicalTrials.gov.

 

Qualifications

You may qualify to participate if you:

  • Are between 18 and 80 years old

  • Have a confirmed diagnosis of celiac disease

  • Have been on a gluten-free diet for the last 12 months

  • Are not pregnant or actively looking to become pregnant

  • Have no history of drug or alcohol abuse in the last 12 months

  • Are willing to take gluten with daily evening meals for 6 consecutive weeks

  • Are willing to travel to the study site in Rochester, Minnesota for 5 study visits
     

Take our pre-screening survey to find out if you qualify. For questions or more information, please contact us.

 

Frequently Asked Questions

 

Participation & Privacy

How long will I participate in the study?


Qualified study participants will be required to attend 5 clinic visits over the course of 14 weeks.




What can I expect if I pre-qualify and decide to participate?


After qualifying through our screening questionnaire, you will be contacted by a member of the research staff to discuss study details, your qualifications, and any questions that you may have. You will receive a copy of the Informed Consent Form which outlines in detail the full inclusion and exclusion criteria required for enrollment, the purpose and structure of the study, and all associated risks, legal information, and safety precautions. Should you continue to qualify and remain interested in particpating, you will be scheduled to attend an in-clinic visit (Visit 1) at the study site in Rochester, Minnesota.




Can I withdraw during the study?


As your participation is voluntary, you can withdraw from the study at any time. You will be asked to attend a final site visit, and return any study-related supplies if you decide to withdraw.




Where does the study take place? Do I have to be located within a specific distance from the study site to participate?


The study site is located in Rochester, Minnesota. You must be able to travel reliably to/from the five study site visits. Participants within a 100-mile radius will receive reimbursement for travel-associated costs.





About Clinical Trials

What is a clinical trial?


After passing extensive pre-clinical testing, an investigational drug's safety and efficacy must be evaluated in people. Clinical trials occur in four phases with increasing populations of volunteers. After each phase, the FDA must approve of the trial's results to allow the drug to move on to the next phase. Celiac Shield is a Phase 2 study designed to test efficacy using a randomized and blinded population of volunteers. For more information on clinical trials, please visit the National Institutes of Health website.




Why should I join a clinical trial?


Clinical trials are the best way to discover new ways of preventing, detecting, and treating diseases. Advances in medicine would not be possible without the participation of volunteers.




What is a placebo?


Determining an investigational drug's effectiveness quickly and reliably requires a comparison to an inactive drug that provides no effect, or a placebo. In blind trials, participants, and often researchers, do not know who is given an active drug or a placebo to avoid any potential bias.




Are clinical trials safe?


Clinical trials are conducted under strict, formalized guidelines of the FDA and operate under the oversight of Institutional Review Boards (IRBs) to ensure that patients’ rights, safety, and privacy are protected.





About the Study

What is celiac disease?


Celiac disease is a genetic autoimmune disorder. When gluten, the name for a set of proteins found in wheat, barley, and rye, is ingested, celiac patients develop an immune response which causes damage to the villi of the small intestine leading to a broad spectrum of gastrointestinal and non-gastrointestinal effects such as abdominal pain, bloating, diarrhea, tiredness, headache, and other symptoms. Damaged villi can lead to malnourishment and a number of diseases including thyroid disorders, autoimmune conditions, and cancer. A lifelong gluten-free diet is the only treatment currently available for people with celiac disease.




Who is the sponsor?


The NIH-funded study is being sponsored by ImmunogenX, a biopharmaceutical company in Newport Beach, California founded in 2013. ImmunogenX is focused on improving the health of people suffering from celiac disease through the exploration of new therapies and diagnostic tools. Learn more at immunogenx.com.




Has the investigational drug been taken before?


The investigational drug was previously evaluated for safety and efficacy in eight clinical studies involving more than 750 patients.




Will I have to ingest gluten? How much?


You will be given gluten in the form of breadcrumbs (approximately one half piece of bread) once daily at your evening meal for six consecutive weeks during which time you will concurrently dose either active study drug or placebo.





Compensation

Do I have to pay to participate?


There is no cost to you to participate in the study.




Is travel to the study site reimbursed?


Travel and lodging expenses may be reimbursed upon qualification. A member of our team will discuss reimbursement options with you.




Will I receive compensation?


Qualified patients may receive compensation after enrollment.





 

Please contact us for more information about participating

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Reference

Jack A Syage, Ciarán P Kelly, Matthew A Dickason, Angel Cebolla Ramirez, Francisco Leon, Remedios Dominguez, Jennifer A Sealey-Voyksner; Determination of gluten consumption in celiac disease patients on a gluten-free diet, The American Journal of Clinical Nutrition, Volume 107, Issue 2, 1 February 2018, Pages 201-207, https://doi.org/10.1093/ajcn/nqx049

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