Gastroenterology, Hepatology & Nutrition Clinical Research

Many children and adolescents with GI disorders have painful and often embarrassing symptoms while others endure debilitating conditions that threaten their life and their way of living. Pediatric GI research is vital, as GI disorders are common among children, and have a tremendous impact on quality of life. 

Clinical researchers at Nationwide Children's are committed to identifying new approaches for the prevention, diagnosis and treatment of childhood diseases, taking research discoveries from the lab to the patient's bedside.

Redefining Health Systems: Hardships, Barriers, and Potential Interventions in Pediatric Inflammatory Bowel Disease

What is the purpose of this study?

This is a study to find out how to make healthcare better for patients with IBD. A lot of people don’t receive good health care. This might be related to problems with the healthcare system, such as issues with insurance, prescriptions, clinics, hospitalizations, and communication with doctors. We think patients and their families can help figure out ways to make things better. So we want to learn about problems you and your family has had with your IBD care.

Who can participate in this study?

This study will be done at Nationwide Children’s Hospital and we hope to enroll 75 participants.

What will happen during this study?

This study involves participating in 3 study visits which occur at the same time as your regular office visits with your doctor and several phone calls. If you agree to be in the study, we will arrange your 3 study visits with your regular doctor’s visits. The first visit will be shortly after being diagnosed with IBD. The second visit will be at about 6 months. The third visit will be at 1 year. You will complete the questionnaires online before your clinic visit. If you are not able to complete the questionnaires before the visit, you can complete them at the clinic visit using a laptop or iPad. The same parent will complete the questionnaires (survey forms) throughout the study. The child will complete the questionnaires if they are a certain age. When possible, we will also invite another parent to participate. The surveys are about quality of life and types of support. The other survey is about types of barriers or challenges that you/your family face as it relates to IBD. It will take about 15-30 minutes to complete the surveys. Study staff will call the parent between study visits. The purpose of the phone calls is to discuss barriers and challenges you/your family face every 6 months and after all clinic visits, procedures, and hospitalizations. This helps learn more about what happens between the 3 study visits while it is still fresh in your mind. You/your family will interact with the health system in many ways at different times. Some examples at the time of diagnosis are clinic visits, lab tests, and scopes. Some patients may need to be admitted to the hospital for flare-ups or have surgery. Some patients have trouble with prescriptions, or insurance. Some patients have trouble scheduling appointments or communicating with their doctor/nurse. It is important to learn about barriers and potential solutions at each of these interactions.

Who can I contact for more information?

If you have questions about this study you may contact the Principal Investigator at (614) 722-3066

Peer Mentoring to Improve Self-Management in Youth With Inflammatory Bowel Disease

What is the purpose of this study?

We are evaluating a mentoring program to help children and teens live well with IBD, and we are comparing it to an educational program.  This study will determine if the mentoring program is helpful, and help improve it.

Who can participate in this study?

  • Youth with IBD ages 10 to 15 can participate in the study (diagnosed at any time).  

  • 16- and 17-year-olds who have been diagnosed with IBD in the past 6 months can participate in the study.

  • People ages 16 – 30 who have had IBD for at least 1 year and are managing it well can participate in the study as mentors after passing a screening process.   

What will happen during this study?

There are 3 study visits for completing questionnaires.  After the first study visit, participants will be put in the Mentoring Program or an Educational Program (there’s a 50/50 chance for each).  The Mentoring Program is a year-long, one-on-one relationship with a mentor with group activities and a parent group.  The Educational Program consists of bimonthly IBD educational group activities for a year.

Who can I contact for more information?

For more details, please contact the Program Coordinator at 614-722-4744.  This study is funded by the Crohn’s and Colitis Foundation of America.

Painless Childhood Study on Stomach Bacteria

What is the purpose of this study?

We are doing this research study to look at the bacteria in the stomach of children.

Who can participate in this study?

Children between 4-12 years of age can participate in this study. We are looking for four groups of children in this age range:

  • Children with autism, with and without stomach pain

  • Siblings of children with autism, with no stomach pain

  • Children without autism and with no stomach pain

  • Children without autism and with stomach pain 

What will happen during this study?

The study includes two visits and a completing a two-week diary of food, stool and stomach pain.

  • The first study visit involves getting consent or approval, providing study information, doing a cheek swab, and receiving surveys that can be done at the visit or taken home.

  • The second study visit involves getting back the completed surveys, getting a stool specimen and being reimbursed for your time.

Participating is easy, and there is no pain involved with either of the two study visits. 

Who can I contact for more information?

For more details, please contact Caitlin Hayes at 614-722-3470. This study is funded by Autism Speaks.

Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn’s Disease

Purpose of study:

Crohn’s Disease is a condition that causes swelling, redness, sores, and pain from the mouth to your bottom, and can cause diarrhea with or without blood. Some children with Crohn’s Disease develop problems such as narrowing of the intestines or blisters in the intestines. However, some children with IBD do not develop these problems. It is not known which children will develop these problems or how long it will take. Certain information stored in the immune system and genes, called “bio-markers”, could help doctors and scientists to identify children who are at risk of developing complications of Crohn’s Disease. We are doing this research study to identify “bio-markers” easily found in blood, stool, or in the lining of the intestines that can help doctors to know which children with Crohn’s Disease are at risk of developing complications quickly. This can help doctors to better treat patients.

Who can participate: 

The study doctor must review all study patients to make sure they meet all of the requirements to be in the study. To be in the study, you must:

Be younger than or equal to 16 years of age.

Have a confirmed or suspected diagnosis of Crohn’s Disease (within the past 30 days). 

Patients must be followed by the GI Clinic at Nationwide Children’s Hospital. 

What will happen during the study: 

This study will last for about 3 years, with 4 visits. Visits will be at Day 1, Month 12, Month 24 and Month 36. These visits will take place at the same time as your regularly scheduled clinic visits.

Blood Samples - If you participate in this study, about 2 teaspoons of blood will be taken at the first study visit. At Visits 2 -4, about 2 teaspoon of blood will be obtained for immune testing.

Stool Samples - You will be asked to provide a stool sample. This sample will be used to look at extremely small microorganisms called microflora, which are always living inside our intestines.

Data - Additional information will also be gathered from your medical chart. This will include information like your age at diagnosis, gender, race and ethnicity, birth history, past medical history, and family history. We will collect information from your regularly scheduled clinic visit as well as your study visits. If you are not seen in clinic at the time points required by the study, we may call you to ask specific medical questions. 

Optional Biopsy

Some patients participating in this study will have a colonoscopy as a part of their standard medical care. A colonoscopy is a procedure where a small, thin tube with a camera on the end is inserted into the rectum and into the intestines. During this procedure, doctors have the ability to take a “biopsy,” or a very small tissue sample about the size of a rice grain from the inside of the intestines. If you are scheduled for a colonoscopy, we would like to collect up to 6 biopsies during the procedure. We would only collect samples once. No further biopsies will be requested. Biomarkers identified in the samples from the intestines will be used to compare with bio-markers found in the blood and stool.

Who to contact: 

Stacy Ballam 614-722-3004
Beth Skaggs 614-722-3487 

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