Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Valley Institute of Research
Location: 1821 Sesame Drive Suite #2 Harlingen, TX 78550 USA
Lead Researcher: Samuel Landero, MD
IRB Committee: This study has been reviewed by the Sterling Institutional Review Board

Background

Celiac disease is a chronic inflammatory autoimmune disorder. It is genetically inherited and happens when one consumes gluten-containing foods (e.g., wheat, barley, and rye). In the United States, about 0.7–1.0% have celiac disease. The only current option for the management of celiac disease is life-long strict adherence to a gluten-free diet. However, only about 45-80% of those who have celiac disease strictly follow a gluten-free diet. 

Researchers are looking for ways to help those diagnosed with celiac disease. This research study seeks to determine if a new potential treatment (Larazotide) will help manage symptoms for those who have been diagnosed with celiac disease while they are on a gluten-free diet. 

This study is looking for adults aged 18 years old or older who have been diagnosed with celiac disease. Interested participants must be on a gluten-free diet. Participants must be willing to comply with all the necessary study requirements for over approximately 30 weeks. Compensation will be provided to eligible participants.

Why Participate? 

• You may experience improvements to your celiac disease symptoms. 
• You may be able to better manage your celiac disease. 
• Compensation of  up to $1,030 will be given to eligible participants for their participation in this study. 
• You may contribute valuable information that may benefit others in the future.
• You will be helping to advance medical research.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Men and women aged 18 years old or older who are diagnosed with celiac disease.
• Participants must have been on a gluten-free diet for at least 6 months.
• Able to attend 8 study visits at the research site as well as comply with the following study requirements for over approximately 30 weeks:
  • The study visits will take about 1 hour to complete.
  • The potential treatment is in the form of a capsule. Participants must agree to take the capsule 3 times a day. It must be taken at least 15 minutes before each meal.
  • Participants must be willing to fill up e-diary entries as well as answer questionnaires.
  • This study will involve blood samples being taken. Participants must be comfortable with having their blood drawn. 

About The Research Center:

Valley Institute of Research
Valley Institute of Research considers local community organizations to be strategic partners with whom underrepresented healthcare service segments are identified and served. Valley Institute of Research also maintains close relationships with their patients and healthy volunteers throughout their health network and our retention practices lead to more successful trial outcomes for our study sponsors.