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.
|
Study Title
|
Gut-Directed Hypnotherapy for Inflammatory Bowel Disease: Recruitment Feasibility Survey
|
|
Description: |
To determine the feasibility of recruiting participants for a clinical trial of gut directed hypnotherapy for Inflammatory Bowel Disease (IBD).
|
|
To Participate: |
-
Patients with IBD, including Ulcerative Colitis, Crohn’s Disease or Crohn’s Colitis.
-
Gastroenterologists currently in practice
|
|
What You Would Have To Do: |
Complete a survey regarding your experiences with IBD.
|
|
How Long Does it take? |
Your participation in this study will involve 1 visit to this website and last for approximately 5 minutes.
|
|
|
This study is conducted
online.
Physicians:
Click Here
Patients:
Click here
|
