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Short Bowel Syndrome clinical trials

View clinical trials related to Short Bowel Syndrome.

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NCT ID: NCT01191177 Withdrawn - Liver Disease Clinical Trials

Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease

Start date: January 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not

NCT ID: NCT01183793 Recruiting - Clinical trials for Short Bowel Syndrome

Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients

Start date: July 2010
Phase: N/A
Study type: Interventional

It is essential to know intestinal length and anastomotic type in post-operative short bowel syndrome patients. These parameters can help predict long-term intestinal failure with long-term parenteral nutrition usually needed for smallest lengths. Sometimes these parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is necessary to develop non-invasive and reproducible techniques to assess small bowel length. This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography and barium follow-through in this indication. There are at this time only two small studies evaluating barium follow-through for intestinal length measurement, and none evaluating MR-enterography. However, a major advantage of the latter is the lack of radiation exposure and possibility to perform 3D. This will be an open labelled single center crossover study. Short bowel syndrome patients of the investigators center will be included after consent. The sequence of exams (MR enterography followed by barium follow-through or vice-versa) will be randomly assigned. Peroperative short bowel length measurement will be available for all patients. There will be one month between the two exams. The main objective of this study is to assess the performance of MR-enterography in short bowel measurement in short bowel syndrome patients, the gold standard being peroperative length. Secondary objectives are to assess the performance of barium follow-through in short bowel measurement in these patients, and to show that barium follow-through does not perform better than MR-enterography. For that purpose the investigators will include 50 patients over 2 years.

NCT ID: NCT00930644 Completed - Clinical trials for Short Bowel Syndrome

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Start date: September 21, 2009
Phase: Phase 3
Study type: Interventional

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

NCT ID: NCT00922805 Withdrawn - Clinical trials for Short Bowel Syndrome

Fiber Use in Pediatric Short Bowel Syndrome

Start date: January 2009
Phase: N/A
Study type: Interventional

Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies. Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children. The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS

NCT ID: NCT00910104 Completed - Clinical trials for Short Bowel Syndrome

Cholestasis Reversal: Efficacy of IV Fish Oil

Reversal
Start date: September 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

NCT ID: NCT00876226 Withdrawn - Clinical trials for Short Bowel Syndrome

Pharmacokinetics of Citalopram in Patients With Short Bowel Syndrome

Start date: May 1, 2010
Phase: N/A
Study type: Interventional

This study will look at how the body interacts with citalopram in adult participants with short bowel syndrome. While information on depression in patients with short bowel syndrome is sparse, the investigators' experience is that these patients have a high incidence of depression and should benefit from a drug intervention.

NCT ID: NCT00798967 Completed - Clinical trials for Short Bowel Syndrome

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

STEPS
Start date: November 25, 2008
Phase: Phase 3
Study type: Interventional

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

NCT ID: NCT00793195 Active, not recruiting - Clinical trials for Short Bowel Syndrome

Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?

Start date: January 2009
Phase: Phase 2
Study type: Interventional

The aim of this study is to determine the feasibility of conducting a trial to examine the efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention of progression of PNALD in infants with Intestinal Failure/Short Bowel Syndrome (SBS) and early liver dysfunction.

NCT ID: NCT00767364 Completed - Clinical trials for Short Bowel Syndrome

Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome

Start date: July 2009
Phase: Phase 1
Study type: Interventional

Rotavirus infection is a common pediatric illness and is the leading cause of severe acute gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of 2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since the FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that it was causing an increase in a gastrointestinal (GI) disease called intussusception. However, the new rotavirus vaccine was studied by the manufacturer and was not found to cause an increase in the cases of intussusception. Intussusception is a disease in which a portion of the GI tract folds back on itself leading to GI tract obstruction or back-up. The manufacturer of the vaccine noted on package insert information that the vaccine was not studied, originally, in infants with a history of GI disorders or in infants who have had surgery on their abdomen. Currently, there is no information available in the scientific literature about the use of the oral rotavirus vaccine in infants with GI diseases or those who have had GI surgeries. The objective of the study is the assessment of safety and tolerability of the oral RotaTeq® vaccine for all infants participating in the study. All infants will be followed for clinical adverse events with active safety surveillance for the first 42 days after each dose and also monthly afterward for a total of 12 months from the first vaccination date. The secondary objective of the study is to quantify the immunologic response will occur in all of the infants in the study. Assessment of percentage of the number of infants who have a good immune response (three-fold rise in IgA titer or greater) to the complete rotavirus vaccine series (three oral vaccines in total) by a blood test to check the rotavirus immunoglobulin A (IgA) level in infants with short bowel syndrome compared to normal infants will occur. Infants, meeting eligibility criteria and whose parents have signed informed consent will have their study information collected. These infants will be tested for the presence of pre-vaccine anti-rotavirus antibody, IgA levels, as mentioned above. After the blood is obtained, participants will receive their first oral rotavirus vaccine dose between the ages of 6 weeks to 12 weeks of life per package insert information. This oral rotavirus vaccine may be administered with other routine pediatric vaccines at the participant primary care provider's office. The date of the rotavirus vaccine and lot number would be recorded on vaccine administration date cards. Most participants will have their vaccines given through the Infectious Disease clinic staff at the Children's Hospital of Michigan. Subsequent doses of the oral rotavirus vaccine will be given at a minimal interval between vaccines of four weeks. The third, and final vaccine dose must be given by 32 weeks of life. Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse Event Reporting System and MedWatch forms. Finally, two weeks after the participants have had all three oral rotavirus vaccine doses, the second and final blood draw will take place for measuring the post-vaccine level of anti-rotavirus antibody, IgA. Participants in the study will be monitored by telephone contacts on days 7, 14, and 42 after each dose and within 48 to 72 hours of each dose of the rotavirus vaccine regarding any serious adverse events. Each infant will also be assessed in the clinical setting each week after a vaccine dose has been given. As above, parents of participants will be asked to fill out the vaccine report card and record the child's temperature, and any episodes of vomiting, diarrhea, blood in the stools or fussiness for the first seven days. The parents will also be asked to record any other events from day 8 through 42 after each vaccine is administered such as fever, ear infection, runny nose, etc. Afterward, parents will also have monthly phone call safety follow-ups during the 12 month period following the first vaccination. A Data Safety and Monitoring Board will oversee the study and it's progress and will have the ability to vote to stop the study.

NCT ID: NCT00742157 Terminated - Clinical trials for Short Bowel Syndrome

Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)

Start date: September 1, 2003
Phase: Phase 4
Study type: Interventional

Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week.