Clinical Research

Clinical research plays a crucial role in our pursuit of understanding and effectively managing pediatric IBD and celiac disease, focusing on research conducted directly with and in collaboration with patients to evaluate treatments, diagnostic methods, and disease management strategies. Clinical research serves as a bridge between the laboratory discoveries of basic science research and the practical application of new therapies and interventions for our young patients.

Our clinical research endeavors encompass several key areas:

Treatment Efficacy and Safety:

Our clinical studies aim to evaluate the effectiveness and safety of various treatments, including medications, dietary interventions, and other therapeutic approaches, in managing pediatric IBD and celiac disease. By rigorously assessing treatment outcomes in a real-world setting, we strive to identify the most optimal and personalized treatment plans for individual patients.

Diagnostic Advancements:

Clinical research involves the development and validation of innovative diagnostic tools and methods for early and accurate detection of pediatric IBD and celiac disease. Through cutting-edge technologies and biomarker assessments, we seek to enhance the efficiency and precision of diagnoses, enabling timely interventions and improved disease management.

Quality of Life and Psychosocial Impact:

We also investigate the psychosocial aspects of living with pediatric IBD and celiac disease. By assessing the emotional and social well-being of our patients and their families, we can develop support programs and interventions that enhance patients’ overall quality of life.

Contact Information

Our researchers are actively involved in basic and clinical research studies. Your child has the opportunity to participate in clinical studies and to benefit from any research advances that are related to improved patient care

If you wish to be involved in our current research efforts, please feel free to contact us at ibdceliacresearch@stanford.edu.

Funding Opportunities
Support Our Center

Clinical Research Program Snapshots

Pediatric IBD and Celiac Disease Biorepository

Faculty Investigators: Michael Rosen, MD, MSCI, Alka Goyal, MD, Dorsey Bass, MD, Nasim Kahavari, 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

Faculty Investigators: Dr. Alka Goyal, MD and Dr. 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 & Clinical Research in IBD (CAPTURE IBD)

Faculty Investigators: Alka Goyal, MD, Michael Rosen, MD, MSCI

This study 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 ofresponse/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. 

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: Michael Snyder, Ph.D, Alka Goyal, MD, 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 & Support Groups

Faculty Investigators: Anava 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: Anava 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). Literature has identified various factors that can make it difficult for a young person to successfully transition from pediatric to adult care. The primary aim of this study is to obtain initial psychometric properties of a newly developed measure of perceived barriers towards transition and transfer. We hypothesize that the transition barriers measure will be a valid and reliable measure of perceived barriers among youth with IBD and their caregiver.

 

Peer Support/Mentorship for Youth with IBD

Investigators: Amy Bugwadia, MS; Anava Wren, PhD; Ashley Dunn, MPH; Rachel Bensen, MD, MPH

This study aims to improve the psychological and social wellbeing of children and teens ages 9-17 who live with IBD, including Crohn's disease and ulcerative colitis, via monthly in-person program sessions. This peer support/mentorship program is created and led by people living with IBD. Program mentors are all young adults with IBD. They will lead each program session, supervised by our IBD team at Stanford. Learn more at http://tinyurl.com/IBDmentee