Cincinnati Children's Intestinal Care Center (CCICC)

Clinical and Basic Research Important to Intestinal Rehabilitation Program’s Continued Success

Integrating research with clinical efforts is one of our core values. The comprehensive nature of research within our center is a major part of what sets Cincinnati Children's Intestinal Care Center apart from other institutions. We work collaboratively to understand the deficits in care and pathophysiology of the disease processes that lead to intestinal failure. The intestinal rehabilitation program has collaborative basic and translational research as well as active clinical trials within the Department of Surgery, Division of Gastroenterology, Hepatology and Nutrition and Division of Neonatology at Cincinnati Children’s.

You and your child are vital members of our research team. More than 80 percent of our patients participate in clinical research protocols, helping us to better understand and treat the diseases that affect them. This patient support is critical to our mission of improving outcomes for children battling intestinal failure which is a rare syndrome.

To learn about clinical research opportunities at the Intestinal Care Center, contact us at 513-636-6155 and ask to speak with one of our research coordinators.

 

The purpose of this research study (link) is to see if giving Omegaven® (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of the intravenous (IV) nutrition therapy may be better tolerated in children with intestinal failure complicated with liver disease.  Researchers are doing this study to see if Omegaven© reduces the harmful effects to the liver, stops any further liver damage, and/or whether it will reverse damage already done to the liver because of the prolonged use of nutrition through your IV. Patients who meet the specific inclusion criteria and managed primarily by our team made be enrolled in this trial.

Omegaven® is an experimental therapy that is not approved by the United States Food and Drug Administration (FDA). 

Clinicaltrials.gov identifier: NCT01173159

 

Teduglutide is a new version of a naturally occurring human glucagon-like peptide-2 (GLP-2) that effects the function and structure of the cells lining the gastrointestinal (GI) tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase villus height and crypt depth in the intestinal epithelium, thereby increasing the absorptive surface area of the intestines. Treatment with this drug of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support has been approved and we are currently testing the safety in the pediatric population.  

Clinicaltrials.gov identifier: NCT01952080

Glutamine (GLN) supplementation has been shown to decrease mucosal damage, lower rates of blood stream infection (BSI) and associated sepsis and improve positive nitrogen balance in adults with short bowel syndrome (SBS). In children, there is currently insufficient data to determine whether enteral GLN supplementation improves clinical outcomes in young infants with significant gastrointestinal resection leading to SBS. The overall purpose of this pilot clinical study is to obtain needed preliminary data on the efficacy of enteral GLN supplementation in children with SBS as a result of significant intestinal resection due to NEC, omphalocele, gastroschisis and intestinal atresia.  

Clinicaltrials.gov identifier: NCT01576003

Our NIH funded basic science program have developed methods to establish long term human cultures from intestinal crypts and isolated intestinal stem cells. This technology has resulted in the creation of our tissue repository making access to both healthy and disease specific intestinal tissues to better understand diseases leading to Intestinal failure. Additional studies have demonstrated our ability to grow fully laminated and functional human intestine from patient specific stem cells. This cutting edge research allows patient specific factors leading to intestinal failure to be studied and opens the door to high throughput drug studies to identify novel therapies to treat short bowel syndrome and other intestinal diseases.
All patients that are cared for in the program are eligible to be enrolled in a prospective registry which allows us to evaluate the predictors of outcomes and also assess the impact of changes in management. The current focus in on improved anthropometrics (Length/height, Weight, BMI) while enrolled in the program and preventing liver disease. As the children grow older, factors that lead to improved developmental outcomes are being assessed.
Using evidence based criteria, patients with intestinal failure and those post small bowel transplant are being monitored for micronutrient malnutrition prior to the onset of clinical symptoms. The micronutrients of interest include iron, zinc, copper, folate, selenium and vitamins A, D, E and K.
Gastroschisis affects approximately 1,800 infants per year in the US. Nearly 2% of those infants are cared for at the Cincinnati Children's Hospital Medical Center neonatal intensive care, making this single center one of the most experienced in the nation in caring for infants with gastroschisis. Feeding related morbidity associated with gastroschisis is high. Infants with gastroschisis have a prolonged perinatal ileus that prevents early feeding. These infants also frequently have intestinal dysmotility, leading to enteral feeding intolerance and subsequent need for parenteral nutrition. Infants with gastroschisis generally remain hospitalized for longer than four weeks as a direct result of enteral feeding intolerance. Optimization of feeding strategies will lead to decreased morbidity, including decreased length of hospitalization, decreased time on parenteral nutrition, decreased risk for sepsis, and improved rates of oral feeding at the time of hospital discharge. Any of these improved outcomes would lead to substantial financial savings to the estimated $225 million spent each year in the U.S. for the care of infants with gastroschisis. We are evaluating different feeding strategies in this population of neonates to identity which is associated with best outcomes regarding tolerating enteral feeds, shortened time on TPN and growth parameters. Further evaluation of these children is also being conducted as they grow to identify the potential impact of nutritional strategies on neurodevelopment.

Clinical Research To Improve Patient Care

Researchers at Cincinnati Children’s engage in a variety of national, multisite research trials and conduct their own clinical studies. Areas of research include:

  • Medical management of pediatric intestinal failure
  • Nutritional management of infants with short bowel syndrome
  • Isolated liver and multivisceral transplantation for total parenteral nutrition-related end-stage liver disease
  • Nutritional and developmental outcomes of infants with intestinal failure and short bowel syndrome
  • Nutritional epidemiology of micronutrient malnutrition in preschool children
  • Development of biomarkers for transplant rejection
  • The role of intestinal microbiota in acute cellular rejection

Our team’s commitment to cutting-edge research is helping to advance the understanding of short bowel syndrome and intestinal failure, and fostering the development of more effective therapies and care protocols.

Why Choose Us?

Our intestinal care center is a specialized center devoted to the care of individuals diagnosed with intestinal failure or other Gastroenterology (GI) dysfunction. Learn More