Clinical Research

We are dedicated to conducting clinical research studies that examine the diverse aspects of inflammatory bowel disease. This includes the physiological and psychological mechanisms of these disorders, as well as health outcomes and quality of life issues that may arise. We also investigate the efficacy of traditional treatments as well as pioneering potential new treatment options for patients affected by IBD.

Visit the GCRC website for more information on academic clinical research.

Current Research Projects (as of October 2006)

We are currently conducting several research projects at the Center and are seeking volunteers.

Study Title

 		 Randomized Clinical Trial to Evaluate the Role of Recombinant Human Growth Hormone (rHGH) on Intestinal Barrier Function
 
Description:

PN associated liver disease is a significant problem in SBS patients and can be lethal. We have noted improvement in liver enzymes in some PN dependent SBS patients that have received rHGH. We hypothesize that this may occur as a consequence of improved intestinal barrier function after rHGH administration. We evaluate intestinal barrier function based on differential permeability to large and small carbohydrates before and after 28 days of rHGH administration. We believe this pilot study will help to determine whether hormonal therapy will be useful in improving intestinal barrier function and preventing PNALD in SBS patients dependent on PN.


Sponsored By:

Independent Medical Grant from Serono
Cost:

There is no cost to you to participate in this study.
Payment:

Travel expenses will be reimbursed only.
To Participate:
  • Over 18 years of age
  • All patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition (PN) or intravenous fluid administration are eligible.

Please contact the study coordinator Anita Wallin at (312) 695-4015 for more details.
What Excludes You:
  • None
What You Would Have to Do:    Please contact the Center for more information.

 

Study Title

 		 A Randomized, Double-Blind, Placebo-Controlled Multi-Center trial of Intravenous Choline Chloride in the Treatment of Hepatic Steatosis Associated with Total Parenteral Nutrition
 
Description:

Patients who are either missing a significant portion of their small intestine (surgery or congenital) or have intestine that does not function normally often require total parenteral (intravenous) nutrition (TPN) at home in order to resume a normal life. One of the complications associated with this therapy is liver failure. Liver disease begins as fatty liver and may progress to cirrhosis and liver failure. This study is designed to determine if the addition of choline (a nutrient) to the TPN solutions will treat fatty liver in patients who have developed that complication.
Sponsored By:

Food and Drug Administration (FDA)
Cost:

There is no cost to you to participate in this study.
Payment:

Travel expenses will be reimbursed only.
To Participate:
  • Over 18 years of age
  • Total Parenteral Nutrition (TPN) providing > 80% of the total daily caloric requirement for a minimum of 12 weeks at the time of trial entry
  • Medical status such that TPN at least five nights weekly is expected to be continued for at least 12 additional weeks at the time of enrollment
  • Life expectancy of at least six months at enrollment and must be able and willing to complete all protocol requirements
  • Stable daily amounts of amino acids, dextrose and lipid for at least three weeks prior to trial enrollment

Please contact the study coordinator Anita Wallen at (312) 695-4015 for more details.
What Excludes You:
  • Serum albumin 3.5 g/L
  • Renal failure requiring hemo- or peritoneal dialysis
  • Hepatic (liver) failure (PT >2x control)
  • AIDS
  • Pregnancy or nursing
  • Patients hospitalized receiving for organ transplant or treatment of rejection
  • > 40 kcal/kg/day ideal body weight
  • Not receiving lipid emulsion as part of the TPN regimen
  • Concurrent cholinergic medication within 14 days of study entry
  • Positive serum pregnancy test for women of child bearing potential or refusal to use an acceptable method of birth control during the study
  • Alcohol abuse
  • Diabetes
  • Intravenous tetracycline, valproic acid, corticosteroids, methotrexate, or amiodorone use
  • Hepatitis C
  • Obesity with ensuing weight loss
  • Use of an investigational drug within 30 days of study entry
What You Would Have to Do:    Complete the following procedures:
  • Blood and urine tests
  • CT scans
  • Physical examinations
  • Complete a nutritional diary
  • Receive an infusion of either choline chloride or a placebo.
  • You will be randomly assigned to one of the two groups. One group will receive their usual TPN to which 2 grams of choline chloride has been added, while the second group will receive their usual TPN to which a placebo, or inactive medication has been added.
How Long Does it take?

The total time to complete the study is approximately 12 weeks.