View clinical trials related to Short Bowel Syndrome.
Filter by:Patients who are being asked to participate in this study have a short small bowel and will be prescribed to take the medication: Zorbtive® ("Zorbtive/Somatropin/(rHGH)"). Zorbtive® is an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if taking this medication improves small bowel function by helping it to take in food, nutrients, vitamins and minerals. The investigators also believe that if the small bowel is absorbing food and nutrients better, liver function will improve as well. Therefore, liver function will also be monitored during the course of the study by performing blood tests.
Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well, and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However, prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies. Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In addition, the premature intestine has a rapid growth rate. It is likely that the current clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet their high metabolic needs. The investigators hypothesize that increasing dietary fat content by early supplementation with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.
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.
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
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.
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.
This is an observational, natural history trial of mechanisms of gut adaptation in adult short bowel syndrome (SBS). Patients with SBS (< 200 cm small bowel ± colon) will be studied initially 2-9 months after the last small bowel resection and again exactly 6 months after the initial study. GCRC-studies will examine intestinal nutrient absorption, gut barrier functions and gut mucosal biopsy specimens for markers of nutrient transport and cell proliferation and apoptosis.
The purpose of this study is to investigate the theory that the plasma level of Glucagon like peptide 2 (GLP-2) in patients with intestinal failure can predict their clinical recovery.
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.