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Last Updated: 10/18/2022

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Sarcopenia and Short Bowel Syndrome: the Microbiota-gut-muscle Axis

Summary: Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. An overabundance of fecal Lactobacillus was found but not yet linked to adaptation or sarcopenia. The objectives are to study the evolution of sarcope...

Quantitative Testing of Patient and Prescriber Knowledge, Attitudes, and Behavior About GATTEX (Teduglutide) for Injection Safety and Use Information

Summary: The main aim of this study is to document the level of knowledge and assess attitudes and behaviors of both participants and physicians regarding the risks and safe use of GATTEX. The survey will be done via internet, telephone, or paper and patients will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.

Improved Quality of Life in Children With Intestinal Failure - a Randomised Intervention Trial

Summary: Children with intestinal failure have a lack of tolerance for food in the intestine. The children are dependent on intravenous nutrition over a long period of time period to ensure growth and development. The condition is characterized by bacterial overgrowth in the intestine, with nausea, vomiting, diarrhea and flatulence as physical symptoms. Mental health is affected in the form of lower qualit...

A 90 Day, Phase 3, Open Labeled Exploratory Study of RELiZORB to Evaluate Safety, Tolerability, and Nutrient Absorption in Children With Short Bowel Syndrome Who Are Dependent on Parenteral Nutrition

Summary: Children with inadequate intestinal absorption due to loss of large amounts of small bowel require intravenous nutrition (feeding through the vein) to sustain hydration and nutrition to avoid starvation and dehydration; however, intravenous (IV) nutrition can lead to complications including liver failure. Tube feeding directly to the small intestine avoids the complications of IV nutrition, but fa...

Non-interventional, Multicenter Retrospective Study of the Effectiveness and Safety of Teduglutide (Revestive®) in Short Bowel Syndrome Adult Patients in Spain (T-Rex Study)

Summary: The main aims of the study are to assess the safety profile of teduglutide (Revestive®) as well as how many people with Short Bowl Syndrome experience a reduction of parenteral support when treated with teduglutide (Revestive®). This study is about collecting existing data only; participants will not receive teduglutide (Revestive®) as part of this study. No new information will be collected durin...

Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition

Summary: Short bowel syndrome (SBS) is defined as a loss of function of the small intestine resulting in a malabsorptive disorder. In SBS, oral drug absorption may be altered due to extensive intestinal resection. It remains unclear to what extent apixaban exposure is impacted in SBS.Therefore this study tries to investigate the pharmacokinetics (PK) of apixaban in adult patients with SBS requiring long-te...

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Summary: The purpose of this study is to determine whether advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures.

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Summary: The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Summary: This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912 in adult subjects with SBS-associated intestinal failure (SBS-IF).

The Rare Disease Clinical Research Network Natural History Study of MNGIE

Summary: This is a multi-center natural history study of Mitochondrial NeurogastroIntestinal Encephalopathy (MNGIE). Patients will be followed over time to assess clinical symptoms. The investigators hope to learn more about the disease of MNGIE as well as develop useful measures of disease status for use in future clinical trials. Additional clinical centers will be listed as they become available.

A Multicentric Observational Retrospective Study on Patients With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Intestinal Transplantation in Brazil

Summary: The main aim of this study is to capture management and treatment outcome data in participants with short bowel syndrome and chronic intestinal failure (SBS-IF) that underwent intestinal transplantation in Brazil. This study is about collecting data available in the participant's medical record and will also describe the demographic and clinical characteristics of these participants. No medication...

Clinical Tolerance and Microbiome Changes Following Fiber Food Introduction in Short Bowel Syndrome

Summary: Short bowel syndrome (SBS) is a rare but challenging condition in which patients have insufficient bowel length to meet fluid, electrolyte, and nutrient requirements without parenteral support. The purpose of this study is to determine how well dietary fiber is tolerated in patients with short bowel syndrome compared to patients without short bowel syndrome based on assessment of gastrointestinal ...

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Last Updated: 10/18/2022