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Short Bowel Syndrome clinical trials

View clinical trials related to Short Bowel Syndrome.

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NCT ID: NCT01696656 Completed - Clinical trials for Short Bowel Syndrome

Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency

Start date: September 2012
Phase: N/A
Study type: Observational

Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Prescriptional pattern of these drugs will be analyzed in a clinical cohort.

NCT ID: NCT01674478 Completed - Prematurity Clinical Trials

Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

EMLFO-2
Start date: October 2012
Phase: Phase 2
Study type: Interventional

Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants. These infants often need surgical intervention to remove the dead bowel and create temporary enterostomies, resulting in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction to digest and absorb nutrients adequately. These infants are often nourished primarily with parental nutrition (PN) which can lead to many complications including PN-associated liver disease. However, with enteral feeding, the remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty acids (LCPUFA) being the most beneficial in promoting bowel adaptation. Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation. Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and increase weight gain in some SBS infants. WThe investigators will soon have completed a randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we were able to decrease the use of IL; (b) premature infants in the treatment group who received ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and better weight gain (g/day) after reanastomosis than those who received routine care in control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in the treatment group than the control group although the difference was not statistically significant. Because the intervention consisted of both an increase in enteral fat intake as well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat intake. Therefore, the investigators have designed a next randomized clinical trial to compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO will result in decreased systemic inflammation, as indicated by blood levels of inflammation-related proteins and indicators of oxidative stress.

NCT ID: NCT01576003 Completed - Nutrition Clinical Trials

Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.

NCT ID: NCT01573286 Terminated - Clinical trials for Short Bowel Syndrome

Safety and Dosing Study of Glucagon-like Peptide 2 (GLP-2) in Infants and Children With Intestinal Failure

GLP-2-01
Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This protocol outlines a randomized,open label trial examining the safety, pharmacology and efficacy of Glucagon like peptide 2 (GLP-2) in infants and children with intestinal failure. The investigators hypothesize that GLP-2 given subcutaneously in these patients will be well tolerated, and have similar metabolism to what has been shown in adults. The investigators also expect to show an improvement in the tolerance of enteral nutrition, and a decreased requirement for intravenous feeding.

NCT ID: NCT01560403 Completed - Clinical trials for Short Bowel Syndrome

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

STEPS3
Start date: May 21, 2012
Phase: Phase 3
Study type: Interventional

This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

NCT ID: NCT01409772 Withdrawn - Clinical trials for Short Bowel Syndrome

Evaluation of 70% Ethanol Lock Solution to Prevent Catheter Related Blood Stream Infections in Pediatric Patients

Start date: May 2009
Phase:
Study type: Observational

The purpose of this study is to evaluate the clinical practice of the prophylactic use of ethanol locks for the prevention of catheter related blood stream infections in pediatric intestinal rehabilitation program patients requiring total parenteral nutrition.

NCT ID: NCT01380366 Completed - Clinical trials for Short Bowel Syndrome

rHGH and Intestinal Permeability in Intestinal Failure

rHGH
Start date: October 2006
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01306838 Completed - Clinical trials for Necrotizing Enterocolitis

Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy

EMLFO
Start date: October 2009
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT01297933 Approved for marketing - Clinical trials for Short Bowel Syndrome

Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease

Omegaven
Start date: n/a
Phase:
Study type: Expanded Access

A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).

NCT ID: NCT01263574 Withdrawn - Clinical trials for Short Bowel Syndrome

Trial of 70% Ethanol Versus Heparin to Reduce the Rate of Central Line Infections in Children With Short Bowel Syndrome

Start date: February 2011
Phase: Phase 2
Study type: Interventional

This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.