Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02561819
Study type Observational
Source Boston Children’s Hospital
Contact
Status Completed
Phase
Start date November 2015
Completion date December 2020

See also
  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
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