Short Bowel Syndrome Clinical Trial
Official title:
Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients
This study will determine if air-displacement plethysmography (ADP) provides accurate measurement of body composition (percent body fat and fat-free mass) in pediatric patients with intestinal failure, as compared to body composition measured by alternative standard methods, including deuterium dilution, bioimpedance analysis (BIA), dual x-ray absorptiometry (DXA) when clinically indicated, and routine anthropometric measurements.
Infants and children with intestinal failure (IF) require prolonged periods of parenteral
nutrition (PN) for sustenance and growth until intestinal adaptation allows adequate enteral
intake. Lean body mass (or muscle mass) preservation and accrual is an important goal during
this phase of nutritional rehabilitation. However, lean body mass is not accurately measured
by currently available anthropometric techniques. Thus, despite weight gain, muscle mass
depletion can remain undetected.
Little data exist in the field of measuring body composition in patients with intestinal
failure, where changes in body weight are commonly taken to indirectly measure
gastrointestinal absorptive function. Body composition analysis is of particular importance
in the management of these patients, since it can help guide medical, surgical and/or
nutrition interventions, including titration of enteral or parenteral nutrition. To the
investigators' knowledge there are no studies examining whether air-displacement
plethysmography (ADP) is a valid measure of body composition in patients with intestinal
failure.
The investigators propose a non-randomized, prospective cohort study to validate ADP as a
measure of body composition in infants and children with IF.
The investigators will apply non-radioactive (stable) isotope techniques to examine the
accuracy of ADP in measuring body composition in these children.
The investigators will also compare ADP with bioimpedance analysis and routine anthropometry.
Additionally, if subjects have had a recent dual-energy X- ray absorptiometry (DXA) scan, the
investigators will compare the ADP estimates of body composition to those obtained from DXA.
The investigators hypothesize that ADP is a feasible and accurate technique for body
composition measurements, and that the device can be used to serially measure lean body mass
and fat mass changes in this cohort. If the feasibility and accuracy of ADP for body
composition analysis can be demonstrated, the technique is likely to have wider applications
in other pediatric illnesses.
;
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 | |
Completed |
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
|
||
Completed |
NCT00067860 -
Diet/Growth Factor Mechanisms of Gut Adaptation
|
Phase 2 | |
Terminated |
NCT04046328 -
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
|
Phase 2 |