Active clinical trials for "Short Bowel Syndrome"

The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).

Short bowel syndrome (SBS) occurs when there is insufficient intestinal mass to support normal growth and development. Approximately 30 out of every 100,000 babies are affected by SBS in North America, and these infants remain dependent on intravenous, parenteral nutrition (PN) for prolonged periods of time. Children with SBS frequently fail to achieve sufficient linear growth and weight gain despite receiving calories in excess of that required by age-matched healthy children. Poor intestinal absorption, motility and increased inflammation all contribute to poor growth in these patients. In addition, children with SBS are known to have significant disturbances to their normal commensal gut bacteria. They may experience a depletion of specific groups of beneficial gut bacteria, and their metabolic by-products, specifically short-chain fatty acids (SCFAs), which can lead to intestinal inflammation, malabsorption, and a less efficient use of consumed calories. In the proposed study, I hypothesize that children with SBS who are given supplements of targeted probiotics will have an increase in beneficial anti-inflammatory bacteria in their gut that more closely resembles the microbiota profile of healthy children. In addition, the children receiving probiotic supplementation will have increased concentrations of fecal SCFAs and improved growth compared to children with SBS who are not receiving supplementation. The central hypothesis will be tested by 1) prospectively characterizing the intestinal bacterial populations (by using next-gen sequencing methods), and measuring SCFA concentrations in the stool of children with SBS receiving probiotic treatment compared to those receiving no supplementation and 2) determining differences in the growth trajectory of the children in both groups by measuring sequential anthropometrics. Enrolled patients will be randomized to either continue with standard of care, or to receive a daily probiotic for 3 months. A total of 3 stool samples will be collected from each patient (at the beginning, midpoint and end of the study) and fecal 16S rDNA microbial sequencing and SCFA concentrations will be compared between groups, as will the groups growth trajectory. The long-term objective of the study is to determine how to effectively change the gut microbiota in children with SBS to restore a healthy balance and maximize growth and development. Although children with SBS have known disturbances to their intestinal microbiota, it is unclear whether providing an oral probiotic is an effective approach to correct these disturbances.

This is a randomized, controlled, unblinded pilot study for patients with vitamin D deficiency in Intestinal Rehabilitation clinic. These patients are not able to absorb oral vitamin D efficiently and thus have a high prevalence of vitamin D deficiency, leading to low bone density. The investigators will use FDA approved portable Ultraviolet B lamp for the intervention group, 11 patients will be recruited from October 2013 to end of January 2014 and study period is 12 weeks for each patient. Study completion will be end of April 2014. Study hypothesis: Ultraviolet B light with a portable ultraviolet device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.

The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada. This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study. Only standard care information available in the participant's medical charts will be reviewed and collected for this study.

The purpose of this study is to evaluate the safety and efficacy of an investigational treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look at how teduglutide moves through the body (pharmacokinetics).

This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.

This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive standard of care. Three doses of teduglutide are to be investigated for 12 weeks. All subjects will be screened prior to the start of treatment (SOT) to establish baseline characteristics including safety, eligibility and nutritional support parameters.

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.

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.

This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.