Active clinical trials for "Short Bowel Syndrome"

The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

The main aims of the study are to check for side effects from teduglutide. Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks. Participants may be able to repeat this treatment if they meet specific criteria. The study doctors will check for side effects from teduglutide until it becomes commercially available. The maximum duration of treatment is approximately 18 months.

This research study was done to see what the effects are of Teduglutide on people with short bowel syndrome (SBS). Teduglutide is a synthetic medication administered as an injection, which has shown to increase intestinal blood flow, inhibit gastric secretion, increase growth of intestinal cells and increase absorption of nutrients. Teduglutide has demonstrated to decrease Total Parenteral Nutrition (TPN) requirements by 20%. Teduglutide is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The primary hypotheses for this study were 1) that Teduglutide significantly increases the gastric emptying half time of solids when compared to placebo. 2) Teduglutide will significantly decrease the intestinal permeability and urinary excretion of lactulose when compared to placebo.

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.

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

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.

The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition complications and to achieve the best possible quality of life for the patient

The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.

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).