Research Center: Valley Institute of Research
Location: 597 W. Sesame Dr., Suite A, Harlingen, TX 78550 USA
Lead Researcher: Dr. Mogbolahan Kuye, MD
IRB: This study has been reviewed and approved by the Advarra Institutional Review Board

Inflammatory bowel disease (IBD) disrupts more than digestion—it disrupts lives. The two most common forms, ulcerative colitis, and Crohn’s disease, cause persistent inflammation and scarring in the gut, making daily life unpredictable and challenging.

While many treatments exist, they don’t work for everyone. That’s why this study is exploring a potential new approach—one that may help reduce symptoms and improve quality of life.

Interested? See if you qualify for this research study.

• Participants may receive a potential new investigative treatment for inflammatory bowel disease (IBD) at no cost.
• Participants will be compensated for each completed visit, with payment provided after each visit.
• Participants will receive reimbursement for pre-approved travel, meal, and lodging expenses.
• Participants may see improvements in their IBD symptoms.
• Participants may contribute to research that could help others living with IBD in the future.
• Participants will play a vital role in advancing medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide 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 16 – 80* who are diagnosed with Crohn’s disease (CD)
• Must weigh at least 40 kg
• Must not have a history of three or more bowel resections
• Must not be missing two or more segments of the terminal ileum, right colon, transverse colon, sigmoid and left colon, or rectum
• Must not have short gut or short bowel syndrome
• Must not have any condition that would prevent an endoscopic evaluation
• Must be willing to have a colonoscopy in the last 2 years to check for abnormal growths or must be willing to have a colonoscopy at screening
• Must be able to attend approximately 36 study visits at the research site over approximately 36 months

Who Can Participate?

• Men and women aged 16 – 80* who are diagnosed with Crohn’s disease (CD)
• Must weigh at least 40 kg
• Must not have a history of three or more bowel resections
• Must not be missing two or more segments of the terminal ileum, right colon, transverse colon, sigmoid and left colon, or rectum
• Must not have short gut or short bowel syndrome
• Must not have any condition that would prevent an endoscopic evaluation
• Must be willing to have a colonoscopy in the last 2 years to check for abnormal growths or must be willing to have a colonoscopy at screening
• Must be able to attend approximately 36 study visits at the research site over approximately 36 months

*Eligibility for people aged 16 and 17 depends on local guidelines and regulations.

The study team will explain the research in its entirety but some details are:

• Participants will complete medical tests, answer questions about their health and medications, and visit the clinic for up to 35 days to check if they qualify.
• Participants will be randomly assigned to receive either the study medication or a placebo.
• Participants will attend follow-up visits and may choose to continue in an extended phase where everyone receives the study medication and is monitored for safety.

Valley Institute of Research
Valley Institute of Research is dedicated to the success of three key stakeholders: patients, physicians within the community, and the pharmaceutical sponsors overseeing clinical trials. Its mission is to conduct research that enhances minority health and reduces health disparities.