Short Bowel Syndrome Clinical Trial
Official title:
Diet/Growth Factor Mechanisms of Gut Adaptation
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05635747 -
A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB
|
||
| Completed |
NCT01891279 -
Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?
|
N/A | |
| Completed |
NCT00930644 -
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
|
Phase 3 | |
| Completed |
NCT01696656 -
Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency
|
N/A | |
| Completed |
NCT00910104 -
Cholestasis Reversal: Efficacy of IV Fish Oil
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04981262 -
Improved Quality of Life in Children With Intestinal Failure
|
N/A | |
| Completed |
NCT01930539 -
Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp
|
N/A | |
| Recruiting |
NCT05023382 -
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
|
||
| Recruiting |
NCT04733066 -
Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
|
||
| Terminated |
NCT00742157 -
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
|
Phase 4 | |
| Completed |
NCT04743960 -
Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
|
N/A | |
| Completed |
NCT03690206 -
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
|
Phase 3 | |
| Terminated |
NCT02266849 -
Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
|
Phase 3 | |
| Completed |
NCT01306838 -
Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy
|
Early Phase 1 | |
| Completed |
NCT01380366 -
rHGH and Intestinal Permeability in Intestinal Failure
|
Phase 4 | |
| Completed |
NCT00248573 -
Mechanisms of Adaptation in Human Short Bowel Syndrome
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03371862 -
Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS)
|
Phase 2 | |
| Completed |
NCT04474743 -
Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
|
||
| Terminated |
NCT04046328 -
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
|
Phase 2 | |
| Completed |
NCT04877431 -
A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease
|