Center for Pediatric IBD and Celiac Disease Clinical Trials and Research

Clinical research is critical to increasing our understanding of the causes of pediatric Inflammatory Bowel Disease (IBD) and Celiac Disease and for developing new treatments. Children are not small adults–they are a unique population with distinct developmental and physiological differences from adults. Pediatric clinical research is needed to 1) understand the root causes of pediatric IBD and celiac disease, 2) developing treatment strategies specifically for children and adolescents, and 3) making medical treatments safer for children. Successful pediatric clinical research studies have the potential to create new standards of care, new therapeutic and treatment options, and meaningfully improve the lives of children with IBD and celiac disease.

The Stanford Medicine Children's Health Center for IBD and Celiac Disease is advancing the care of children with IBD and celiac disease everywhere through research. Composed of leading gastroenterologists and health care specialists, our Center integrates state-of-the-art interdisciplinary clinical care with cross-cutting innovative research to meaningfully improve the lives of children and adolescents affected by IBD and Celiac Disease. Our research is designed to improve the diagnosis, treatment, and prevention of IBD and Celiac Disease in children, as well as advance the current knowledge of these diseases.

Our investigative efforts focus on the following areas of interest:

• Developing noninvasive techniques to monitor disease.
• Investigating environmental factors in the development and course of IBD and Celiac Disease.
• Evaluating how psychosocial support for children and families affects symptom management and emotional well-being.
• Studying the impact of integrative GI therapies on disease management and quality of life.
• Learning how to create the most effective personalized pharmacotherapy (medication) plans by studying how drugs and the body affect each other.
• Exploring how we can change the health care system to improve care for children with IBD and Celiac Disease.
• Discovering ways to use nutritional therapies to manage Crohn’s Disease and Ulcerative Colitis.

You and your child can participate in clinical studies at Stanford University School of Medicine. Many of our studies bring children, families, clinicians, and researchers together to collaborate as equal and reciprocal contributors to produce new knowledge to improve health care and health outcomes. Talk with your provider about joining the most suitable active study that excites you.

If you are interested in learning more about these studies, feel free to contact us at pedsibdceliacresearch@stanford.edu.

Research studies

Current studies

Pediatric IBD and Celiac Disease Biorepository
Faculty Investigators: Michael Rosen, MD, MSCI, Alka Goyal, MD, Dorsey Bass, MD, Nasha Khavari, MD, MPH, Rachel Bensen, MD

A biorepository is a collection of human biological tissue specimens and related health data used for research purposes. This research study aims to create a biorepository consisting of blood, tissue, and stool samples from pediatric patients diagnosed with inflammatory bowel disease (IBD), celiac disease or are undergoing evaluation for a possible digestive disorder in order to learn more about IBD and celiac disease and to develop new diagnostic tools and treatments for pediatric patients. Participants will be asked to donate blood, tissue, urine, and/or stool samples at their routine blood draws or already scheduled endoscopic procedures.

Adaptive Immune Response to SARS-CoV-2 Vaccine in Children with Inflammatory Bowel Disease
Faculty Investigators: Alka Goyal, MD, Hayley Altman Gans, MD

This research study seeks to understand how children who are on medications that suppress their immune systems, such as those used to manage IBD, respond to the SARS-CoV-2 vaccine by examining reactive T-cells to SARS CoV-2 and cellular immunity. The study involves 1-3 blood draws to measure patients’ antibody and T-cell responses to their SARS-CoV-2 vaccine. Patients between 5-17 years old with inflammatory bowel disease (IBD) who have received at least 2 doses of mRNA SARS-CoV-2 vaccine. Children who have received IVIg infusions and who have had COVID infection may participate.

Determining the Role of the Appendix in Pediatric Ulcerative Colitis
Faculty Investigators: Dorsey Bass, MD

This study examines the role of the appendix in the development of ulcerative colitis (UC) in youth to better understand the relationship between UC and appendix inflammation. The study also examines the diversity of bacteria in the appendix in children with UC compared to those with Crohn’s disease. This data will help improve the understanding of the immune system and clinical care for patients.

Cohort for Pediatric Translational and Clinical Research in IBD (CAPTURE IBD)
Faculty Investigators: Alka Goyal, MD, Michael Rosen, MD, MSCI

This is a prospective cohort study that aims to create a prospective cohort of pediatric IBD patients with active disease initiating or changing medical, dietary, or surgical therapy. The study will identify unique subgroups of pediatric patients with high likelihood of response/non-response to specific therapies through integrated analysis of demographic, clinical, and multi-omic molecular data. It also aims to define surgical, clinical, and endoscopic outcomes of ileal surgery for pediatric Crohn’s disease and clinical and molecular predictors of post-operative endoscopic disease recurrence. This is an observational non-interventional study and will not interfere with clinical care.

Study procedures consist of blood sample collection when phlebotomy venipuncture is already performed for clinical purposes, non-invasive collection stool, questionnaires, and additional endoscopic biopsies when a lower gastrointestinal endoscopy with biopsy is performed for clinical care.

Learn more at https://bit.ly/captureibd

Crohn’s Exposome
Faculty Investigators: Alka Goyal, MD, Michael Snyder, PhD, Sarah Streett, MD

This study aims to understand the relationship between diet and other environmental factors, and their impact on Crohn’s disease. Information will be gathered from wearable devices that measure things such as step count, body movement, electrical changes in the skin related to stress, skin temperature, location, air cleanliness, blood oxygen level, blood pressure, urine, certain characteristics of the stool (including a good and bad bacteria count), and blood chemicals. The study examines factors such as diet, stress, exercise, and particles in the air and their relation to the onset or flares of Crohn’s disease.

Learn more at https://snyderlabs.stanford.edu/crohnsexposome/

ImproveCareNow
Faculty Investigators: Rachel Bensen, MD, MPH

ImproveCareNow strives to transform the health, care and costs for all children and adolescents with Crohn’s disease and ulcerative colitis (UC). Patients, families, clinicians and researchers work together in a sustainable collaborative chronic care network to accelerate innovation, discovery and application of new knowledge and conduct health services, outcomes, and comparative effectiveness (CE) research. This study uses patient data to transform care and improve outcomes for children, adolescents and young adults with inflammatory bowel disease (IBD).

Learn more at https://www.improvecarenow.org/

Mind-Body Coping Skills and Support Groups for Youth with IBD and Celiac Disease
Faculty Investigators: Ana Wren, PhD, Molly Tanenbaum, PhD

Inflammatory bowel disease (IBD) and celiac disease can negatively impact children and adolescents’ psychological, social, and physical well being. Research has shown that coping skills and support groups can improve mental health, physical health, and quality of life. This study investigates the effects of coping skills and support groups for youth with IBD and celiac disease and their parents. The study also explores if these groups can improve psychological, social, and health outcomes among these youth. This research will help better understand patient’s personal experiences with these diseases and help improve future support and coping skills groups. This will also inform future clinical care and research on the emotional and physical well being of youth.

Transition Barriers: Initial Validation
Faculty Investigators: Ana Wren, PhD, Rachel Bensen, MD, MPH

The transition and transfer to adult care is a daunting time for youth with chronic health conditions such as inflammatory bowel disease (IBD). Extant literature has identified various factors that can impede this process, making it difficult for a young person to successfully move across the pediatric to adult health care continuum. The primary aim of this study is to obtain initial psychometric properties of a newly developed measure of perceived barriers towards transition and transfer. There is no currently available measure of transition/transfer barriers; as such this project is exploratory in nature. We hypothesize that the transition barriers measure will be a valid and reliable measure of perceived barriers among youth with IBD and their caregiver.