Short Bowel SyndromeNCT02561819
Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients
An observational study of Short Bowel Syndrome, run by Christopher Duggan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Short Bowel Syndrome
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with intestinal failure between 2-17 years of age inclusive will be recruited through the Center for Advanced Intestinal Rehabilitation (CAIR) program at Boston Children's Hospital.
Who may be able to join
- Patients evaluated in the CAIR Program at Boston Children's Hospital will be eligible for participation if they meet the definition of short bowel syndrome and are under 18 years of age. Short bowel syndrome will be defined as a malabsorptive state resulting from congenital or acquired gastrointestinal disease leading to current dependence on parenteral nutrition for greater than or equal to 90 days. If the patient is on intravenous fluids, they must have a stable intravenous fluid regimen for at least 4 weeks prior to the study visit.
Who cannot join
- age < 2 years or ≥ 18 years
- presence of cardiac pacing device (BIA may theoretically interfere with pacer functioning)
- presence of any other electrical device that might interfere with the BIA such as implantable drug delivery pumps, vagal nerve stimulator and invasive cerebral perfusion monitor
- subjects will be excluded due to pregnancy
- subjects with ongoing fluid imbalance, clinically evident shifts in fluid compartments (e.g. edema, ascites) or with fluid resuscitation (defined as daily fluid intake more than 150% of maintenance or fluid boluses more than 20 ml/kg/day). Determination of fluid imbalance will be made by the physicians directly involved in the patient's care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed 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.
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel Syndrome, Congenital Short Bowel Syndrome, Body Composition, Parenteral Nutrition, Intestinal Failure
- Medical subject headings
- Short Bowel Syndrome, Intestinal Pseudo-Obstruction, Hyperphagia, Intestinal Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition (percent body fat and fat-free mass) as measured by air displacement plethysmography in pediatric patients with intestinal failure on date of visit.
Body composition (percent body fat and fat-free mass) as measured by air displacement plethysmography in pediatric patients with intestinal failure will be compared to body composition measurements done by the deuterium dilution technique, DXA scan, and bioimpedance analysis.
Measured: Single Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher Duggan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Duggan, Boston Children's Hospital
- Investigators
- Christopher Duggan, MD, MPH, Principal investigator, Boston Children's HospitalAlexandra Carey, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561819
- Sponsor's protocol ID
- IRB-P00014026
- Status last verified
- Dec 2019
- First submitted
- 25 Sep 2015
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
O'Keefe SJ, Buchman AL, Fishbein TM, Jeejeebhoy KN, Jeppesen PB, Shaffer J. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol. 2006 Jan;4(1):6-10. doi: 10.1016/j.cgh.2005.10.002.
PubMed 16431298Gosselin KB, Duggan C. Enteral nutrition in the management of pediatric intestinal failure. J Pediatr. 2014 Dec;165(6):1085-90. doi: 10.1016/j.jpeds.2014.08.012. Epub 2014 Sep 18. No abstract available.
PubMed 25242686Winkler MF, Smith CE. Clinical, social, and economic impacts of home parenteral nutrition dependence in short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):32S-37S. doi: 10.1177/0148607113517717. Epub 2014 Jan 13.
PubMed 24418898Squires RH, Duggan C, Teitelbaum DH, Wales PW, Balint J, Venick R, Rhee S, Sudan D, Mercer D, Martinez JA, Carter BA, Soden J, Horslen S, Rudolph JA, Kocoshis S, Superina R, Lawlor S, Haller T, Kurs-Lasky M, Belle SH; Pediatric Intestinal Failure Consortium. Natural history of pediatric intestinal failure: initial report from the Pediatric Intestinal Failure Consortium. J Pediatr. 2012 Oct;161(4):723-8.e2. doi: 10.1016/j.jpeds.2012.03.062. Epub 2012 May 11.
PubMed 22578586Sharma TS, Bechard LJ, Feldman HA, Venick R, Gura K, Gordon CM, Sonis A, Guinan EC, Duggan C. Effect of titrated parenteral nutrition on body composition after allogeneic hematopoietic stem cell transplantation in children: a double-blind, randomized, multicenter trial. Am J Clin Nutr. 2012 Feb;95(2):342-51. doi: 10.3945/ajcn.111.026005. Epub 2011 Dec 28.
PubMed 22205317Murphy AJ, Wells JC, Williams JE, Fewtrell MS, Davies PS, Webb DK. Body composition in children in remission from acute lymphoblastic leukemia. Am J Clin Nutr. 2006 Jan;83(1):70-4. doi: 10.1093/ajcn/83.1.70.
PubMed 16400052Burnham JM, Shults J, Semeao E, Foster BJ, Zemel BS, Stallings VA, Leonard MB. Body-composition alterations consistent with cachexia in children and young adults with Crohn disease. Am J Clin Nutr. 2005 Aug;82(2):413-20. doi: 10.1093/ajcn.82.2.413.
PubMed 16087987Stallings VA, Tomezsko JL, Schall JI, Mascarenhas MR, Stettler N, Scanlin TF, Zemel BS. Adolescent development and energy expenditure in females with cystic fibrosis. Clin Nutr. 2005 Oct;24(5):737-45. doi: 10.1016/j.clnu.2005.02.005. Epub 2005 Apr 8.
PubMed 16182037Farrell AG, Schamberger MS, Olson IL, Leitch CA. Large left-to-right shunts and congestive heart failure increase total energy expenditure in infants with ventricular septal defect. Am J Cardiol. 2001 May 1;87(9):1128-31, A10. doi: 10.1016/s0002-9149(01)01479-5. No abstract available.
PubMed 11348620Ellis KJ, Shypailo RJ, Wong WW. Measurement of body water by multifrequency bioelectrical impedance spectroscopy in a multiethnic pediatric population. Am J Clin Nutr. 1999 Nov;70(5):847-53. doi: 10.1093/ajcn/70.5.847.
PubMed 10539745Elberg J, McDuffie JR, Sebring NG, Salaita C, Keil M, Robotham D, Reynolds JC, Yanovski JA. Comparison of methods to assess change in children's body composition. Am J Clin Nutr. 2004 Jul;80(1):64-9. doi: 10.1093/ajcn/80.1.64.
PubMed 15213029Ginde SR, Geliebter A, Rubiano F, Silva AM, Wang J, Heshka S, Heymsfield SB. Air displacement plethysmography: validation in overweight and obese subjects. Obes Res. 2005 Jul;13(7):1232-7. doi: 10.1038/oby.2005.146.
PubMed 16076993Gately PJ, Radley D, Cooke CB, Carroll S, Oldroyd B, Truscott JG, Coward WA, Wright A. Comparison of body composition methods in overweight and obese children. J Appl Physiol (1985). 2003 Nov;95(5):2039-46. doi: 10.1152/japplphysiol.00377.2003.
PubMed 14555670Schoeller DA, van Santen E, Peterson DW, Dietz W, Jaspan J, Klein PD. Total body water measurement in humans with 18O and 2H labeled water. Am J Clin Nutr. 1980 Dec;33(12):2686-93. doi: 10.1093/ajcn/33.12.2686.
PubMed 6776801Van Kreel BK, Van der Vegt F, Meers M, Wagenmakers T, Westerterp K, Coward A. Determination of total body water by a simple and rapid mass spectrometric method. J Mass Spectrom. 1996 Jan;31(1):108-11. doi: 10.1002/(SICI)1096-9888(199601)31:13.0.CO;2-M.
PubMed 8799264
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients
- ClinicalTrials.gov ID
- NCT02561819
- Acronym / sponsor ID
- IRB-P00014026
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel Syndrome, Congenital Short Bowel Syndrome, Body Composition, Parenteral Nutrition, Intestinal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Christopher DugganUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2020
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with intestinal failure between 2-17 years of age inclusive will be recruited through the Center for Advanced Intestinal Rehabilitation (CAIR) program at Boston Children's Hospital.
Key inclusion criteria (1 listed)
- Patients evaluated in the CAIR Program at Boston Children's Hospital will be eligible for participation if they meet the definition of short bowel syndrome and are under 18 years of age. Short bowel syndrome will be defined as a malabsorptive state resulting from congenital or acquired gastrointestinal disease leading to current dependence on parenteral nutrition for greater than or equal to 90 days. If the patient is on intravenous fluids, they must have a stable intravenous fluid regimen for at least 4 weeks prior to the study visit.
Key exclusion criteria (5 listed)
- age < 2 years or ≥ 18 years
- presence of cardiac pacing device (BIA may theoretically interfere with pacer functioning)
- presence of any other electrical device that might interfere with the BIA such as implantable drug delivery pumps, vagal nerve stimulator and invasive cerebral perfusion monitor
- subjects will be excluded due to pregnancy
- subjects with ongoing fluid imbalance, clinically evident shifts in fluid compartments (e.g. edema, ascites) or with fluid resuscitation (defined as daily fluid intake more than 150% of maintenance or fluid boluses more than 20 ml/kg/day). Determination of fluid imbalance will be made by the physicians directly involved in the patient's care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body composition (percent body fat and fat-free mass) as measured by air displacement plethysmography in pediatric patients with intestinal failure on date of visit.
Time frame: Single Visit
Body composition (percent body fat and fat-free mass) as measured by air displacement plethysmography in pediatric patients with intestinal failure will be compared to body composition measurements done by the deuterium dilution technique, DXA scan, and bioimpedance analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 16431298O'Keefe SJ, Buchman AL, Fishbein TM, Jeejeebhoy KN, Jeppesen PB, Shaffer J. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol. 2006 Jan;4(1):6-10. doi: 10.1016/j.cgh.2005.10.002.
- Background: PubMed 25242686Gosselin KB, Duggan C. Enteral nutrition in the management of pediatric intestinal failure. J Pediatr. 2014 Dec;165(6):1085-90. doi: 10.1016/j.jpeds.2014.08.012. Epub 2014 Sep 18. No abstract available.
- Background: PubMed 24418898Winkler MF, Smith CE. Clinical, social, and economic impacts of home parenteral nutrition dependence in short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):32S-37S. doi: 10.1177/0148607113517717. Epub 2014 Jan 13.
- Background: PubMed 22578586Squires RH, Duggan C, Teitelbaum DH, Wales PW, Balint J, Venick R, Rhee S, Sudan D, Mercer D, Martinez JA, Carter BA, Soden J, Horslen S, Rudolph JA, Kocoshis S, Superina R, Lawlor S, Haller T, Kurs-Lasky M, Belle SH; Pediatric Intestinal Failure Consortium. Natural history of pediatric intestinal failure: initial report from the Pediatric Intestinal Failure Consortium. J Pediatr. 2012 Oct;161(4):723-8.e2. doi: 10.1016/j.jpeds.2012.03.062. Epub 2012 May 11.
- Background: PubMed 22205317Sharma TS, Bechard LJ, Feldman HA, Venick R, Gura K, Gordon CM, Sonis A, Guinan EC, Duggan C. Effect of titrated parenteral nutrition on body composition after allogeneic hematopoietic stem cell transplantation in children: a double-blind, randomized, multicenter trial. Am J Clin Nutr. 2012 Feb;95(2):342-51. doi: 10.3945/ajcn.111.026005. Epub 2011 Dec 28.
- Background: PubMed 16400052Murphy AJ, Wells JC, Williams JE, Fewtrell MS, Davies PS, Webb DK. Body composition in children in remission from acute lymphoblastic leukemia. Am J Clin Nutr. 2006 Jan;83(1):70-4. doi: 10.1093/ajcn/83.1.70.
- Background: PubMed 16087987Burnham JM, Shults J, Semeao E, Foster BJ, Zemel BS, Stallings VA, Leonard MB. Body-composition alterations consistent with cachexia in children and young adults with Crohn disease. Am J Clin Nutr. 2005 Aug;82(2):413-20. doi: 10.1093/ajcn.82.2.413.
- Background: PubMed 16182037Stallings VA, Tomezsko JL, Schall JI, Mascarenhas MR, Stettler N, Scanlin TF, Zemel BS. Adolescent development and energy expenditure in females with cystic fibrosis. Clin Nutr. 2005 Oct;24(5):737-45. doi: 10.1016/j.clnu.2005.02.005. Epub 2005 Apr 8.
- Background: PubMed 11348620Farrell AG, Schamberger MS, Olson IL, Leitch CA. Large left-to-right shunts and congestive heart failure increase total energy expenditure in infants with ventricular septal defect. Am J Cardiol. 2001 May 1;87(9):1128-31, A10. doi: 10.1016/s0002-9149(01)01479-5. No abstract available.
- Background: PubMed 10539745Ellis KJ, Shypailo RJ, Wong WW. Measurement of body water by multifrequency bioelectrical impedance spectroscopy in a multiethnic pediatric population. Am J Clin Nutr. 1999 Nov;70(5):847-53. doi: 10.1093/ajcn/70.5.847.
- Background: PubMed 15213029Elberg J, McDuffie JR, Sebring NG, Salaita C, Keil M, Robotham D, Reynolds JC, Yanovski JA. Comparison of methods to assess change in children's body composition. Am J Clin Nutr. 2004 Jul;80(1):64-9. doi: 10.1093/ajcn/80.1.64.
- Background: PubMed 16076993Ginde SR, Geliebter A, Rubiano F, Silva AM, Wang J, Heshka S, Heymsfield SB. Air displacement plethysmography: validation in overweight and obese subjects. Obes Res. 2005 Jul;13(7):1232-7. doi: 10.1038/oby.2005.146.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Duggan, MD, MPH principal investigator
Boston Children's Hospital
Alexandra Carey, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome, run by Christopher Duggan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (percent body fat and fat-free mass) as measured by air displacement plethysmography in pediatric patients with intestinal failure on date of visit. (time frame: Single Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02561819, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.