Clinical Trials / Research Studies

Clinical Trials / Research Studies

Inflammatory Bowel Disease (IBD) Study for Young Adults 18 to 25 Years Old

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the effects of adding a prebiotic dietary supplement to the treatment plan of young adults with IBD.

Who can participate?

Young adults 18 to 25 years old who have been diagnosed with Crohn’s disease or ulcerative colitis who are taking a stable maintenance medication may be eligible to participate.

Conditions

  • Crohn's Disease and Colitis
  • Gastroenterology, Hepatology and Nutrition
  • Adult Studies

What will happen in the study?

This study includes 4 study visits over a 5 month period and a telephone contact prior to each study visit.

Participants will be randomized (selection random like flipping a coin) to receive 1 of 3 doses of a prebiotic or a placebo (looks like the supplement but does not contain the prebiotic). The study supplement will be in a single dose packet, and you will take the study supplement once per day in the morning with water.

Throughout the study, we will review your electronic medical record to obtain any relevant information such as medical history, medication changes, etc.

Here are some of the other things that will happen in this study:

You will:

  • Submit saliva and blood samples
  • If female and having a menstrual cycle, have a pregnancy test
  • Submit symptom questionnaires to report any symptoms related to your IBD
  • Complete quality of life questionnaires
  • Have physical exams
  • Submit stool samples (can be collected at home with a stool collection kit we will give you)
  • Be asked to report what you have eaten in the past 24 hours either over the phone or at a study visit at an unannounced day and time
  • Be asked to report any symptoms such as stomach pain and diarrhea while taking the prebiotic/placebo using the GSRS (Gastrointestinal Symptom Rating Scale) symptom questionnaire.

We will ask you to record each daily dose of the study supplement.

You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

You may not have a direct medical benefit. If you receive the prebiotic, it may promote healthy bacteria in your intestine. However, being in this study may not help you right now.

When we complete this study, we hope that we will know more about IBD and how to best treat it. This may help other children and adults with IRB in the future.

What are the bad things that can happen from this research?

We will discuss possible risks and discomforts with those wanting to learn more about the study.

Will you/your child be paid to be in this research study?

You will receive up to $280 for 4 study visits.

Contact

Contact Us.Ramona Bezold
513-636-1412
ramona.bezold@cchmc.org
Gastroenterology, Hepatology & Nutrition
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Lee Denson, MD
Gastroenterology, Hepatology & Nutrition
Cincinnati Children’s Hospital Medical Center