Gastroenterology, Hepatology & Nutrition Clinical Research

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.

Hypnotherapy for Children During Anorectal Manometry

This study aims to investigate the utility of hypnotherapy during anorectal manometry to decrease periprocedural distress and anxiety.

Principal Investigator: Fredrick Woodley, PhD

Identifying Biomarkers of GI Morbidity in Autism Spectrum Disorders: Linking Multi-Omics and Human Behaviors

This study aims to characterize and correlate the functional gut microbiome and metabolome in children with autism, neurotypical healthy children and children with functional GI disorders. In addition, we seek to characterize the gut microbiome in children with autism spectrum disorders, unaffected siblings and healthy children.

Principal Investigator: Kent Williams, MD

Understanding Pediatric GI Providers’ Perceptions of and Engagement with Psychosocial Professionals

This study seeks to understand pediatric GI providers’ perceptions of and engagement with psychosocial professionals (e.g., social work, psychology). 

Principal Investigator: Jennifer Dotson, MD, MPH

Celiac Kids Internet Diet Survey (CeliacKIDS)

This study aims to develop a self-administered standardized assessment of gluten exposure risk for children and/or parents of children with celiac disease; provide evidence of psychometric soundness (e.g., reliability, validity) of this instrument in assessing gluten-free diet adherence. In addition, assess the effectiveness of current educational strategies in equipping patients with celiac disease and their families with the knowledge required to reduce gluten exposure. Explore the relationship between Neighborhood-Disadvantage and gluten exposure risk.

Principal Investigator: Tracy Ediger, MD, PhD

Evaluation of the EliA Celikey IgA and Inova Quantaflash CIA IgA tTG Assays to Predict Intestinal Damage Consistent With Celiac Disease in Pediatric Patients Undergoing Upper Endoscopy

This is a prospective, single center study comparing 100 children with celiac disease with 500 children without celiac disease. The aim of this study is to: (1) determine whether a tTG antibody level greater than 10 times the ULN as determined by means of the EliA Celikey IgA assay and INOVA QUANT Flash CIA IgA tTG assay can accurately predict the presence of Marsh III changes on small intestinal histology; (2) determine the sensitivity and specificity of the EliA Celikey IgA (anti-tTG) and INOVA QUANTA Flash CIA IgA tTG assay for identifying children with biopsy confirmed Celiac disease; (3) create a urine bank of patients with celiac disease so that urine may be analyzed in the future for potential markers of celiac disease.

Principal Investigator: Tracy Ediger, MD, PhD

Safety and Efficacy of Oral Medicine in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects (age 18 and older) with cystic fibrosis-related exocrine pancreatic insufficiency. The study’s overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003.

Principal Investigator: A. Jay Freeman, MD, MSc

3D High-Resolution Anorectal Manometry: A Novel Technique to Study Children With Constipation Study

This study aims to evaluate whether there is agreement between findings on conventional anorectal manometry and 3D anorectal manometry, and to assess whether 3D anorectal manometry has additional value over conventional anorectal manometry in the evaluation of children with constipation.

Principal Investigator: Desalegn Yacob, MD

Air-Swallows and GERD-Like Symptoms Study

This study aims to assess the potential association of air swallows (and other esophageal air disturbances such as supragastric and gastric belches) with symptoms once thought to be caused by gastroesophageal reflux.

Principal Investigator: Fredrick Woodley, PhD

Anorectal Manometry Research Database Study

This study aims to generate a database of anorectal manometry (ARM) test findings to allow better evaluation of and understanding of the normal and abnormal ranges, trends and characteristics in the pediatric population referred for ARM testing.

Principal Investigator: Peter Lu, MD

Efficacy and Safety of Rizatriptan for Aborting Cyclic Vomiting Syndrome Attacks in Children and Adolescents in the Pre-Hospital Setting: A Randomized Controlled Pilot Trial

This study aims to evaluate the efficacy of rizatriptan for aborting acute cyclic vomiting syndrome attacks, and evaluate the safety and tolerability of rizatriptan for this indication.

Principal Investigator: Peter Lu, MD

Functional and Motility-Related GI Disorders Review Study

This study aims to generate a database of all functional and motility-related GI disorders with their demographic, historical and medical information to allow for better understanding of the patient population’s characteristics and health outcomes.

Principal Investigator: Peter Lu, MD

High-Resolution Colonic Manometry in Children With Chronic Intractable Constipation Study

This study aims to quantify the colonic motor patterns in children with chronic intractable constipation by retrospectively analyzing high resolution colonic manometry tracings. These data will then be compared to the previously published manometric findings from healthy adults and adults with slow transit constipation and to manometric findings from children with intractable constipation from unpublished Netherlands data.

Principal Investigator: Desalegn Yacob, MD

Impact of COVID-19 on Children with Functional Abdominal Pain Disorders

This study aims to evaluate the impact of COVID-19 on clinical and behavioral outcomes of children with functional abdominal pain disorders.

Principal Investigator: Peter Lu, MD

Patterns and Costs of Emergency Care and Hospitalization for Children and Adolescents with Cyclic Vomiting Syndrome: A PHIS Database Analysis

This study aims to evaluate the cost of emergency department use and hospitalization for children and adolescents with cyclic vomiting syndrome over five years. 

Principal Investigator: Peter Lu, MD

Pediatric Constipation Score Survey Study

This study aims to gather information on patient and parent perspectives on constipation severity.

Principal Investigator: Peter Lu, MD

Pediatric Gastroparesis Registry Study

This is a national prospective registry of children and adolescents with gastroparesis and gastroparesis-like syndrome to include demographic, clinical, psychological, nutritional characteristics, physiological measures and serial assessments of symptoms over three years while receiving clinical care. In addition, it will establish a biorepository of plasma, serum, peripheral blood mononuclear cells, GI mucosal biopsies, urine and stool collected from the children and adolescents in this registry which will allow for future analyses such as cytokines, bacterial DNA and microbiome to investigate the etiology and pathogenesis of gastroparesis in children.

Principal Investigator: Kent Williams, MD

Prospective Observational Study on Prognostic Factors and Outcome After Antegrade Continence Enemas in Children With Severe Chronic Defecation Disorders

This study aims to assess the outcome of pediatric patients that undergo ACE procedures for defecation disorders.

Principal Investigator: Desalegn Yacob, MD

Randomized, Single Blinded Trial Comparison of Pyloric Muscle Botulinum Toxin Injection Versus Pyloric Muscle Botulinum Toxin Injection and Pyloric Balloon Dilation in Pediatric Patients With Gastroparesis, Functional Nausea, Functional Dyspepsia or Functional Vomiting

This study aims to evaluate if either intervention, pyloric muscle injection of botulinum toxin alone, versus pyloric muscle injection of botulinum toxin and pyloric muscle balloon dilation, will lead to earlier and more prolonged improvement of symptoms; to evaluate if either intervention leads to decreased medication use over the study period, change in weight, improvement in oral intake; to determine feasibility of using our questionnaire to evaluate the efficacy of pyloric botox with and without pyloric balloon dilation 

Principal Investigator: Karla Vaz, MD

Withholding During Colonic Manometry in Children: Can You Stop a High Amplitude Propagating Contraction?

This study aims to determine whether a child is able to terminate a high amplitude propagating contraction by withholding. 

Principal Investigator: Peter Lu, MD

Hearing Status of Children and Adolescents with Familial Adenomatous Polyposis

This study aims to obtain preliminary data on the hearing status of children and adolescent with familial adenomatous polyposis (FAP) in a standardized manner according to national guidelines and to compare this to data from siblings of a similar age or age and socioeconomic matched controls.

Principal Investigator: Steve Erdman, MD

Hirschsprung Disease Research Collaborative

This multicenter study will collect detailed clinical information, including phenotypic data, to accelerate progress in understanding the genetic basis of Hirschsprung disease. Broadly, clinical information will be used to investigate possible genotype – phenotype correlations and their relationship with medical, surgical and pathological data on patients.

Principal Investigator: Cheryl Gariepy, MD

Prevalence of Functional GI Disorders in Pediatric Patients with Trisomy 21

This is a single-center survey study of the parents of children with Trisomy 21 ages 4 to 18 years that will determine the prevalence of functional GI disorders based on the Rome IV criteria.

Principal Investigator: Steven Ciciora, MD

Anti-TNF Therapy for Refractory Colitis in Hospitalized Children (ARCH)

This is a multicenter observational study investigating factors predicting early clinical response in hospitalized children with severe steroid-refractory ulcerative colitis or inflammatory bowel disease-unclassified.

Principal Investigator: Brendan Boyle, MD, MPH

Assessing Multidisciplinary Provider Perspectives on Medical Decision-Making and Education Related to Ostomy Surgery in Pediatric Patients With IBD

This study aims to understand how multidisciplinary providers coordinate and collaborate on medical decision-making and education related to ostomy surgery for pediatric patients with IBD, as well as identify barriers and recommendations for improved coordination and collaboration for this population.

Principal Investigator: Jennie David, PhD

Assessing Post-operative Recurrence in Pediatric Crohn’s Disease

This study aims to determine post-operative recurrence in children with Crohn’s disease and evaluate potential risk factors that influence disease course following surgical intervention.

Principal Investigator: Ross Maltz, MD

Assessing the Durability of Anti-TNF Medications in Pediatric IBD

This study aims to evaluate the risks of loss of response to anti-TNF medications in pediatric IBD and potential risk factors. 

Principal Investigator: Ross Maltz, MD

Blood and Stool Molecular Biomarkers Detection Study in Pediatric Crohn’s Disease Patients Study (Prometheus)

This study aims to evaluate the effectiveness of the Prometheus Monitor test to predict disease status in pediatric Crohn’s disease patients. 

Principal Investigator: Jennifer Dotson, MD, MPH

Clinical and Molecular Signature to Predict Response to Biologic Therapy in Pediatric IBD: A Multicenter Observational Study Targeting the Inflammatory Signature to Personalize Biologics in Pediatric IBD (REFINE)

This multicenter observational study aims to identify biomarkers of treatment response to infliximab and vedolizumab in children with IBD.

Principal Investigator: Brendan Boyle, MD, MPH

Data-Driven Approach for Risk Stratification and Outcome Prediction for Pediatric Inflammatory Bowel Disease Study: The Data Linkage Study

This study will build a risk prediction model for pediatric inflammatory bowel disease (IBD) to predict patient outcomes and facilitate efficient decision support for personalized care. Specifically, it aims to develop a machine-learning based clinical pathway learning algorithm for pediatric IBD that predicts for three outcomes of interest: (1) sustained remission/flare; (2) surgery and (3) hospitalization.

Principal Investigator: Jennifer Dotson, MD, MPH

Impact of a Biofeedback Intervention on Microbiome, Metabolome and Clinical Outcomes in Pediatric IBD

This study aims to determine whether stress reduction through biofeedback therapy effects disease activity, symptoms, stress, depression, quality of life, stress-related changes in the microbiome and metabolome.

Principal Investigator: Ross Maltz, MD

Intestinal Disease Biobank: Genetic, Functional and Microbial Studies in Intestinal Disease (NEOPICS)

This study involves biobanking of biological specimens from patients with very early onset of inflammatory bowel disease diagnosed at 6 years old or under to identify applicable genes to improve diagnosis, predict treatment response and impact long-term outcomes. 

Principal Investigator: Ross Maltz, MD

Long Term Outcomes Using Nutrition Therapy in Pediatric Crohn’s Disease

This retrospective review evaluates 6- and 12-month outcomes for patients with Crohn’s disease treated with nutrition therapy in the induction and maintenance phases. 

Principal Investigator: Brendan Boyle, MD, MPH

Pediatric Prospective on Biosimilars and Non-Medical Switches in Pediatric Inflammatory Bowel Disease

This study evaluates pediatric patients and their guardian’s perception on biosimilars and non-medical switches in inflammatory bowel disease patients.

Principal Investigator: Ross Maltz, MD

Peer Mentoring to Improve Self-Management in Youth with IBD

This is a multicenter randomized controlled trial to evaluate a multifaceted peer mentoring program to improve quality of life and health outcomes compared to an educational activity program

Principal Investigator: Laura Mackner, PhD

Pharmacodynamic Targets to Enrich Personalized Anti-TNF Dosing Study (RADAR)

This multicenter cross-sectional study aims to identify biochemical and drug concentration targets for pediatric Crohn’s disease treatment response to anti-TNF therapy. 

Principal Investigator: Brendan Boyle, MD, MPH

Precision Crohn’s Disease Management Utilizing Predictive Protein Panels (ENVISION)

This study aims to identify proteins predicting favorable outcomes for patients initiating anti-TNF therapies. 

Principal Investigator: Brendan Boyle, MD, MPH

Predicting Response to Standardized Pediatric Colitis Therapy (PROTECT)

This multicenter open-label study evaluates the safety and efficacy of standardized initial therapy using either mesalamine, or corticosteroids then mesalamine, for the treatment of children and adolescents newly diagnosed with ulcerative colitis. 

Principal Investigator: Brendan Boyle, MD, MPH

Randomized, Double-Blind, Placebo-controlled, Multi-center Pragmatic Clinical Trial to Evaluate the Effectiveness of Low Dose Oral Methotrexate in Patients with Pediatric Crohn’s Disease Initiating Anti-TNF Therapy (COMBINE)

The aim of this multicenter randomized controlled trial is to determine whether the addition of low-dose oral methotrexate (MTX) leads to better outcome in children with Crohn’s disease (CD) initiating anti-TNF therapy compared to children treated with monotherapy.

Principal Investigator: Brendan Boyle, MD, MPH

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

This prospective longitudinal study assesses health systems and related barriers from the patient, family and provider’s perspective and access potential personalized health care system solutions to the identified barriers.

Principal Investigator: Jennifer Dotson, MD, MPH

Relation of Social Factors with Racial Disparities in Pediatric Inflammatory Bowel Disease: The SaFR Kids Study

This cross-sectional study compares social constructs including household income, parental health literacy, parental distrust in the health care system and time needed to travel to see an IBD specialist among children of different race and ethnic groups within the United States.

Principal Investigator: Jennifer Dotson, MD, MPH

Retrospective Cohort Study of Very Early Onset IBD: (VEOIBD)

This multicenter study will describe the clinical and phenotypic characteristics of very early onset inflammatory bowel disease (VEOIBD) at presentation and the use and outcomes of medical and surgical therapies among patients with inflammatory bowel disease before the age of 6 years.

Principal Investigator: Ross Maltz, MD

Retrospective Review of Efficacy, Safety and Tolerability of Therapies in Pediatric Ulcerative Proctitis

This study is a retrospective chart review of Nationwide Children’s Hospital cohort of patients with ulcerative proctitis, with specific attention to efficacy of therapies, adverse events, relapse of disease with discontinuation of therapy, proximal extension of disease and colectomy rates.

Principal Investigator: Jonathan Gisser, MD

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

The aim of this multicenter observational study designed to validate a risk stratification model for predicting severe and complicated disease phenotype in children with Crohn’s disease. 

Principal Investigator: Jennifer Dotson, MD, MPH

Understanding the Impact of Telemedicine on IBD Care

This study explores the impact of telemedicine upon the care delivered to patients with IBD, including access to care and MyChart use. 

Principal Investigator: Hilary Michel, MD

Using Patient Data to Transform Care and Improve Outcomes for Children, Adolescents and Young Adults with Inflammatory Bowel Disease: The ICN Registry Study

The aim of this multicenter registry database is to capture clinical data to support better clinical care, quality improvement efforts and assess changes in the clinical outcomes of children with inflammatory bowel disease. 

Principal Investigator: Brendan Boyle, MD, MPH

Circulating Anti-Myenteric Antibodies in Pediatric Irritable Bowel Syndrome

This study aims to investigate the relationship between serum anti-myenteric antibodies and irritable bowel syndrome in children and adolescents.

Principal Investigator: Jonathan Gisser, MD

Evaluating the Efficacy of the Low-FODMAP Diet for Children with Irritable Bowel Syndrome Study

This study aims to evaluate the effectiveness, feasibility and safety of the low-FODMAP diet in children with IBS. In addition, we seek to determine if an IBS patient’s microbiome and metabolites is predictive of who will respond to a low-FODMAP diet and evaluate the affect a low-FODMAP diet has on the microbiome and metabolites. 

Principal Investigator: Peter Lu, MD

Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

This is a study to look at the effect of amoxicillin, a commonly used antibiotic in children, on the motility of the stomach and small intestine in children. Motility disorders in children can present in a variety of ways, including abdominal pain and vomiting, and can have a significant impact on their well-being. Unfortunately, there are few available medications that are effective in treating these disorders.

Principal Investigator: Carlo Di Lorenzo, MD

Evaluation of the Efficacy of Open Label Placebo in Children with FGIDs (Functional Gastrointestinal Disorders)

This is a prospective crossover study of the efficacy of administering placebo to children with functional gastrointestinal disorders without deception.

Principal Investigator: Karla Vaz, MD

Limited Access Protocol for the Use of Oral Cisapride in the Treatment of Pediatric Patients and Adult Patients With Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders

This is a compassionate use study to allow the use of cisapride by patients with gastroesophageal reflux disease, gastroparesis, pseudo-obstruction or severe chronic constipation who have failed standard therapy. 

Principal Investigator: Steven Ciciora, MD

Retrospective Review of Treatment With Aprepitant, Pyridostigmine, Baclofen or Linaclotide For Children With Functional and Gastrointestinal Motility Disorders

This study aims to review and evaluate outcomes after children with functional or gastrointestinal motility disorders were treated with novel motility medications, including aprepitant, pyridostigmine, baclofen or linaclotide.

Principal Investigator: Peter Lu, MD

Long-Term Outcomes of Gastric Electrical Stimulation in Children with Nausea and Vomiting Study

This study aims to describe gastric electrical stimulation patient outcomes, including clinical outcomes, perceived benefit, patient satisfaction and complications.

Principal Investigator: Peter Lu, MD

Prospective, Controlled Trial of Gastric Electrical Stimulation in Children With Nausea And Vomiting

This prospective, single-blinded, controlled trial of gastric electrical stimulation would compare clinical symptoms when the stimulator is turned off versus turned on. This trial is conducted during a two-week observation period, during which temporary GES is applied prior to permanent stimulator implantation as part of Nationwide Children’s Hospital’s institutional clinical treatment protocol.

Principal Investigator: Peter Lu, MD

This study aims to determine the effect of posterior tibial nerve stimulation (PTNS) on children with constipation due to pelvic floor dyssynergia.

Principal Investigator: Peter Lu, MD

2’-Fucosyllactose and Gut Motility in Human Subjects Study

The aim of this study is to determine whether direct administration of 2’FL to the intestinal mucosa results in a reduction in the amplitude, velocity and frequency of migrating motor complexes in pediatric patients exhibiting normal MMC patterns during fasting periods.

Principal Investigator: Peter Lu, MD

Identifying Essential Fatty Acid Deficiency in an At-Risk Population

This study aims to estimate the prevalence of essential fatty acid deficiency among pediatric patients prescribed exclusive enteral nutrition and cared for by a large pediatric complex care practice. It will compare essential fatty acid status by primary diagnosis, nutrition status and enteral nutrition details. It will also evaluate for a linear relationship between essential fatty acid content of enteral nutrition and serum levels.

Principal Investigator: Ethan Mezoff, MD

Impact of Human Milk Oligosaccharide 2’-Fucosyllactose on Growth, Feeding Progression and Neurodevelopment in Preterm Infants

The overall goal of this study is to test daily oral administration of 2’-FL 250 mg/day in the milk of human milk and formula-fed infants who are >1,000 grams to <1,500 grams birthweight. We will compare weight, length and head circumference Z-score growth between the 2’-FL and placebo groups. In addition, we will compare the time taken to achieve full feedings (135 mL/kg/day or more) between the 2’-FL and placebo groups.

Principal Investigator: Ethan Mezoff, MD

Multicenter Retrospective Review of Imaging Findings of Chronic Pancreatitis Study

Despite the fact that imaging plays a significant role in the diagnosis/confirmation of chronic pancreatitis in children, cross-sectional imaging (CT and MRI) findings of pediatric chronic pancreatitis remain largely subjective and agreement between radiologists on those findings has not been assessed in a pediatric population. This multi-institutional study will define inter-observer agreement on imaging findings of chronic pancreatitis in children.

Principal Investigator: Cheryl Gariepy, MD

Pancreatitis in the Complex Care Population

This is a retrospective chart review covering a 10-year period ending 12/31/2019, which will describe the incidence, severity and associated findings in complex care patients diagnosed with pancreatitis or having an elevated serum lipase.

Principal Investigator: Cheryl Gariepy, MD

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

This multicenter study will comprehensively characterize the pediatric population with acute recurrent pancreatitis and chronic pancreatitis and determine predictors of early onset chronic pancreatitis and its sequelae.

Principal Investigator: Cheryl Gariepy, MD

Rumination Management in the Era of Telehealth Study

The aim of this study is to evaluate the impact of telehealth in the clinical management of rumination symptoms.

Principal Investigator: Peter Lu, MD

Survey on Outcomes of Childhood Rumination Syndrome Study

The aim of this study is to evaluate the outcomes of rumination syndrome in pediatric patients.

Principal Investigator: Peter Lu, MD

Bedside Percutaneous Endoscopic Gastrostomy Tube Placement in the Chronically Ill Neonate

This is a retrospective chart review of infants that have undergone bedside sedated PEG placement over the past seven years at Nationwide Children’s Hospital. The aim of this study is to compare these infants to the ones that underwent PEG placement under general anesthesia during the same time period. In addition, we seek to better define the risks, complications and benefits of sedated PEG placement in this population in order to be better identify infants that should or should not undergo gastrostomy tube placement by this method.

Principal Investigator: Steve Erdman, MD

Coffee During Colonic Manometry in Children: Does Coffee Act as a Colonic Stimulant?

The aim of this study is to determine if coffee stimulates colonic motility in children.

Principal Investigator: Peter Lu, MD

Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. difficile Infection in Pediatric and Young Adult Patients

This study aims to employ fecal microbiota transplantation as a therapy for pediatric and adolescent Clostridium difficile infection using protocols currently employed elsewhere in the United States among adults and children.

Principal Investigator: Jonathan Gisser, MD

Skin Patch for Monitoring Cystic Fibrosis Health and Adherence Study

Sweat will be collected in two ways: the classic method using the Macroduct® system and the new skin patch system, from both cystic fibrosis and non-cystic fibrosis subjects. For cystic fibrosis subjects, we will collect sweat samples when they are admitted into the hospital for pulmonary exacerbation and then again just prior to their discharge. We will analyze the samples using mass spectroscopy to identify metabolites that will allow us to distinguish patients in pulmonary exacerbation from those who are not in pulmonary exacerbation with the goal of identifying a pattern of metabolites in sweat that can be used to non-invasively run surveillance to identify early stages and potentially treat pre-emptively to prevent the pulmonary exacerbation. 

Principal Investigator: Fredrick Woodley, PhD