Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248573
Status:
COMPLETED
Last Update Posted:
2013-12-17
First Post:
2005-11-03
Brief Title:
Mechanisms of Adaptation in Human Short Bowel Syndrome
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational natural history trial of mechanisms of gut adaptation in adult short bowel syndrome SBS Patients with SBS 200 cm small bowel colon will be studied initially 2-9 months after the last small bowel resection and again exactly 6 months after the initial study GCRC-studies will examine intestinal nutrient absorption gut barrier functions and gut mucosal biopsy specimens for markers of nutrient transport and cell proliferation and apoptosis
Detailed Description:
Short bowel syndrome SBS is a condition that occurs after massive surgical removal of sections of the small bowel required to treat conditions such as Crohns disease lack of adequate blood flow to the intestine trauma twisting of the bowel and other disorders Patients with SBS develop severe diarrhea weight loss loss of nutrients in the stool malnutrition dehydration and deficiency of specific nutrients SBS is thus a major cause of intestinal failure in adults and children SBS has a high rate of death and medical complications and patients experience enormous health care-related costs and decreased quality of life Patients with SBS often require intravenous feeding known as parenteral nutrition PN due to chronic malabsorption and malnutrition and also commonly develop infections from intestinal bacteria suggesting abnormalities in the intestinal barrier to bacteria present in the intestine In animal models of SBS increased growth of the intestinal lining mucosa and improved nutrient absorption occur over time intestinal adaptation Although SBS patients commonly exhibit decreased diet-induced diarrhea within the first 2 years after intestinal surgery very little is known about how the intestinal mucosa adapts in patients with SBS The proposed pilot study will be the first comprehensive study of serial changes in gut mucosal structure and function in the early period 2-30 months of SBS in humans Our Specific Aims are designed to determine 1 whether the residual small bowel and colonic mucosa in SBS patients exhibits adaptive growth with concomitantly improved nutrient absorption and gut barrier function 2 The underlying mechanisms of early gut adaptation in human SBS by evaluating changes in mucosal cell growth and production of key molecules that are responsible for nutrient transportabsorption and gut barrier function and 3 The utility of plasma citrulline concentrations and serum flagellin antibody titers as markers for human intestinal absorptive capacity and gut barrier function respectively Our research will provide important and new information on the natural history and underlying causes of early intestinal adaptation in man This information will be valuable in the design of future therapeutic studies in patients with SBS that hold promise for improving the rehabilitation of these individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03DK067123 | NIH | None | httpsreporternihgovquickSearchR03DK067123 |