Purpose: With data from the ImproveCareNow Registry, we aim to determine the trajectory, risk factors, and impact of abdominal pain in youth with IBD during the first year after diagnosis. We hope that findings from this study may inform future screening and intervention approaches for youth with IBD with persistent abdominal pain.

Primary Outcome: Abdominal pain

Study Period: Jan-Dec 2019

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: ImproveCareNow Research 

Additional links

Research Explained - on LOOP 

Abdominal Pain After Pediatric IBD Diagnosis on PubMed 

Purpose: The purpose of this study is to evaluate pediatric GI providers' practices and attitudes toward use of mind body interventions (MBI) for patients with inflammatory bowel disease (IBD)?

Specific Aims:

1) Examine pediatric GI providers’ attitudes and perceptions towards MBI as adjunct therapy for pediatric IBD

2) Identify barriers to recommendation of MBI

3) Assess need for further training in MBI for pediatric GI providers

4) Determine if there are differences in practices based on demographic variables (e.g., provider type, age and geographic location of practice)

Start Date: September 2017

Contact: Ann Ming Yeh

Study Authors: Jennie G David, PhD, Douglas Chute, PhD, Bonney Reed, PhD, Shehzad Saeed, MD, David DeMatteo, JD, PhD, Orhan Atay, MD, Michele Maddux, PhD, Brian Daly, PhD

Study Period: 2017-2021

Additional links

Assessing the Prevalence of and Risk Factors for Disordered Eating Attitudes and Behaviors in Adolescents With Inflammatory Bowel Disease

Study Authors: Moses J, Sandberg K, Winberry G, Riera D, DeLozier S, Gupta SK, Reilly N, Park KT, Picoraro J.

Purpose: Endoscopic remission has become a standard treatment target in inflammatory bowel disease (IBD). It is unclear how widely this practice has been adopted amongst pediatric gastroenterology providers. This study determines the frequency of repeat endoscopy in pediatric IBD and evaluates for predictive baseline characteristics of providers.

Study Period: Dec 2019-Dec 2020

Publication: Moses J, Sandberg K, Winberry G, Riera D, DeLozier S, Gupta SK, Reilly N, Park KT, Picoraro J. Clinical Practice Survey of Repeat Endoscopy in Pediatric Inflammatory Bowel Disease in North America. J Pediatr Gastroenterol Nutr. 2021 Feb 24. doi: 10.1097/MPG.0000000000003100. Epub ahead of print. PMID: 33633082.

Contact: ImproveCareNow Research 

Additional links

Clinical Practice Survey of Repeat Endoscopy in Pediatric Inflammatory Bowel Disease in North America on PubMed 

Purpose: The COMBINE Trial will study if treatment with a single anti-TNF medication (infliximab and adalimumab) or dual therapy that includes methotrexate is more effective in children with moderate to severe Crohn’s disease. COMBINE is the first study to look at this question in children with Crohn’s disease. We expect that 425 kids from across the US will enter the study. The results of this study can be used to help doctors choose medications that help children the most.

Funding Source (Year Awarded): Patient Centered Outcomes Research Institute (2015)

Study Period: 2015-2020

Recruitment Status: Complete - Manuscript published April 2023 in Gastroenterology

For more information

Clinical Research 101

Researchers Announce Findings from Landmark Clinical Trial for Pediatric Crohn's Disease - UNC Health

ICN Posts

ICN Research Explained: The COMBINE trial 

ImproveCareNow Researchers Announce Findings From Landmark Clinical Trial for Pediatric Crohn's Disease 

PCORI funding approved for pragmatic clinical trial to compare combination versus monotherapy in children with Crohn's disease


Purpose: To characterize current practices surrounding depression screening in pediatric Inflammatory Bowel Disease (IBD) care

Primary Outcome: Clinical practices around depression screening

Study Period: November 2019-February 2020

Recruitment Status: No longer recruiting participants

Contact: Michele Maddux


Purpose: Genotypes that result in deficient activity of the thiopurine-methyltransferase (TPMT) enzyme may confer increased risk of myelosuppression for patients treated with azathioprine. TPMT is essential to the metabolism of azathioprine and is involved in the folic acid metabolism pathway. Therefore, we propose the dietary folic acid supplementation mitigates azathioprine-induced myelosuppression irrespective of TPMT genotype. Hypothesis: Folic acid supplementation mitigates azathioprine-induced myelosuppression in pediatric IBD.

Primary Outcome: 

  • Discern if folic acid supplementation mitigates azathioprine-induced myelosuppression

Secondary Outcome: 

  • Discern how many patients receive folic acid supplementation in addition to azathioprine treatment.
  • Discern the TPMT genotype and phenotype of patients with IBD who develop myelosuppression while on azathioprine

Funding Source: Center for Undergraduate Excellence, Chapman University

Study Period: June 2019- May 2020

Final Abstract

Contact: John Miklavcic; (714-516-5520) 


Purpose: This study uses data from the ImproveCareNow Registry to examine the duration and effectiveness of Adalimumab therapy in pediatric Crohn’s Disease within the ICN network.  This knowledge is an important step in learning how to optimize the use of Adalimumab.

Funding Source: AbbVie (2016)

Study Period: 2015-2017

Recruitment Status: This study makes use of existing data in the ICN registry. 

Contact: ImproveCareNow Research 

More Information:

ImproveCareNow registry used to evaluate use of concomitant immunomodulators with adalimumab therapy in Crohn's Disease

Evaluation of adalimumab effectiveness in anti-tumor necrosis factor-naïve pediatric patients with Crohn's disease in clinical practice

Putting Data to Work to Answer Questions: Evaluation of Adalimumab Effectiveness


Purpose: By using data that exists in the ImproveCareNow Registry, this study aims to measure the duration and effect of adalimumab on clinical outcomes in pediatric ulcerative colitis patients in the clinical practice setting.  This study will add to the knowledge about the use of adalimumab as therapy in the management of pediatric ulcerative colitis.

Funding Source (Year Awarded): AbbVie (2016)

Study Period: 2016-2017

Recruitment Status: This study makes use of existing data in the ICN registry. 

Contact: ImproveCareNow Research

More information:

Evaluation of adalimumab effectiveness in paediatric patients with ulcerative colitis in clinical practice


Purpose: The GROWING study, which stands for Predictors of continued statural GROWth IN older adolescents and younG adults with Crohn’s disease and ulcerative colitis, aims to determine the prevalence of continued growth and to quantify total height gain and height velocity in older adolescents and young adults with Crohn’s disease and ulcerative colitis after the chronological age of expected growth plate closure. We will determine predictors and associative factors of continued growth in these patients.

Funding Source (Year Awarded): Celgene (September 2016)

Study Period: February – December 2017

Recruitment Status: No longer recruiting participants


Gupta N, Liu C, King E, Sylvester F, Lee D, Boyle B, Trauernicht A, Chen S, Colletti R, ImproveCareNow Network . Continued statural growth in older adolescents and young adults with Crohn's disease and ulcerative colitis beyond the time of expected growth plate closure.  Inflamm Bowel Dis 2020

Determined the frequency of continued growth and compared the total height gain beyond the time of expected growth plate closure and the chronological age at achievement of final adult height in Crohn's disease (CD) vs ulcerative colitis (UC) and described height velocity curves in inflammatory bowel disease (IBD) compared with children in the National Health and Nutrition Examination Survey (NHANES).

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Purpose: This study will randomize participants to either eight sessions of online mindfulness-based treatment ("standard") or a briefer, three-session online mindfulness-based treatment ("light") to compare the treatments' efficacy and acceptability across a wide range of conditions and special populations. 

Funding Source: PCORI (2016)

Study Period: May 2016-October 2019

More information:

PCORI.org - Healthy Mind, Healthy You 

ImproveCareNow Network to Participate in $4 Million Research Study Comparing Stress Management Approaches




Purpose: This study is investigating whether obesity is associated with worsening disease outcomes in children with Crohn’s disease. In particular, we will be reviewing data from ICN to see if children with newly diagnosed Crohn’s disease had differing Crohn’s disease outcomes at 1 year based on weight status (obese, overweight, normal weight).  The results of this study could help understand whether obesity impacts Crohn’s disease, which could be a potential treatment goal for children.

Primary/Secondary Outcomes:

  • Primary Outcomes: Proportion of children in Crohn’s disease remission at 1 year
  • Secondary Outcomes: Growth, laboratory markers of Crohn’s disease (such as sedimentation rate and blood count), steroid free remission, and disease activity based on objective indices all at 1 year.

Contact: Animesh Jain

Publication: Overweight and obese status is not associated with disease activity for children and adolescents with newly diagnosed IBD


Co-Principal Investigators: 

Marc Schaefer, MD, MPH - Penn State Hershey Children’s Hospital

Jeanne Tung, MD - The Children’s Hospital at Oklahoma University

Purpose: Transition of care and transfer of care are two major areas of IBD care that should receive significant attention because they have major potential for quality improvement.  This survey will provide the ICN Transition of Care Task Force with more information about the number of centers providing transition education, the transition tools they are using, and how they are using these tools.  It will also provide us with information on transfer of care, such as what age patients are being transferred and how does the hand-off of clinical information occur at the time of transfer.

Primary/Secondary Outcomes:

  • Primary Outcome: Identify the centers in ImproveCareNow providing transition education
  • Secondary Outcome: Identify the centers in ImproveCareNow that have a transfer process for their patients

Study Period: Survey conducted in the fall of 2015.

Contact: Marc E. Schaefer, MD, MPH

Additional Links

Implementing Transition & Transfer of Care Systems in Pediatric IBD


Purpose: Our goal for this study is to figure out the best way to collect information during a clinic visit about the current symptoms patients are experiencing and then use that information to improve the care patients receive during the visit.

Funding Source (Year Awarded): PCORI (2016)

Study Period: March 2017 – March 2019

Contact: ImproveCareNow Research






Co- Investigators: David Suskind, MD, Shehzad Saeed, MD & Kimberly Braly, RD

Clinician Stakeholders: Jennifer Burgis, MD & Kaylie Nguyen, PNP

Parent Stakeholders: Sheri Pilley, Julie Stone, Gisele Woodward

Patient Stakeholders: Catalina Berenblum

Purpose: PRODUCE study, which stands for Personalized Research on Diet in Ulcerative Colitis and Crohn’s Disease, is a first of its kind nutrition intervention study in IBD. With evidence showing dietary intervention has an impact on disease activity for patients with IBD, the PRODUCE study aims to determine the effectiveness of the Specific Carbohydrate Diet (SCD) in reducing symptoms and inflammatory burden in patients with IBD and compare this to a modified form of the SCD. Over the course of this project, a series of N-of-1 studies will be used to examine how the SCD affects individual patients. In addition, we will combine the results of approximately 100 individual N-of-1 studies to look at the effectiveness of the SCD in the pediatric IBD population.

Primary Outcomes: Patient reported outcomes of:

  • Daily stool frequency
  • Daily stool consistency
  • Weekly PROMIS Pain Interference
  • Weekly PROMIS GI symptom severity
  • Fecal calprotectin

Secondary Outcomes: 

  • Short Crohn’s Disease Activity Index (SCDAI)
  • Clinically-evaluated disease activity scores and laboratory markers contained in ICN registry:
    • PUCAI and SPCDAI
    • Growth
    • CRP, HCT, Albumin, ESR
  • Microbiome analyses

Funding Source: Patient Centered Outcomes Research Institute (PCORI; Awarded January 2017)

Study Period: January 2017 – January 2020


Heather Kaplan, MD, MSCE - Co-PI

Lisa Opipari-Arrigan, PhD - Co-PI 

Cassandra Dodds - Clinical Research Coordinator 

Lauren Murphy - Clinical Research Coordinator 

For More information:
Blog posts

Purpose: The purpose of this study is to study the proteome that could serve as biomarkers and identify individuals who have IBD or might be at risk for developing IBD.

Specific Aims:

  1. To evaluate the proteome in ten family members in 5 families who have at least 4 affected individuals
  2. To evaluate the genome using the Illumina GSA  chip in the 10 enrolled members of each family

Study Period: January 2019-December 2019

Contact: Harland Winter

Purpose: The purpose of this study is to evaluate knowledge and investigate whether health care providers educate patients about effects of ileal pouch-anal anastomosis (IPAA) surgery (also known as J pouch surgery) on fertility. 

Study Period: March 2021-July 2021

Contact: Rachel Winter

Study Authors: David, JBerenblum Tobi, CKennedy, S, et al.

Purpose: This paper, written by patients and providers from ICN, reviews current ICN data on PAC‐generated resources, including creation processes and download statistics.

Study Period: Jul 2020-Feb 2021

Publication: David, J, Berenblum Tobi, C, Kennedy, S, et al. Sustainable generation of patient‐led resources in a learning health system. Learn Health Sys. 2021;e10260. https://doi.org/10.1002/lrh2.10260

Contact: ImproveCareNow Research 

Additional links

Research Explained on LOOP

Sustainable generation of patient‐led resources in a learning health system

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