Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
NCT ID: NCT03105362
Last Updated: 2020-02-24
Study Results
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View full resultsBasic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2017-08-16
2018-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Amino Acid-ORS arm
Patients consumed an amino acid based oral rehydration solution (enterade®) as part of their oral rehydration care plan. Enterade® oral rehydration solution volumes varied from patient to patient depending on baseline clinical need.
Enterade® oral rehydration solution
Commercially available amino acid based oral rehydration solution
Interventions
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Enterade® oral rehydration solution
Commercially available amino acid based oral rehydration solution
Eligibility Criteria
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Inclusion Criteria
* Patients who are in intestinal continuity or with diverting ileostomy, jejunostomy
* Patients must be on a stable enteral nutrition regimen with oral rehydration fluids that are taken orally.
* Stable GI medication regimen (e.g., loperamide, cholestyramine, small bowel bacterial overgrowth (SBBO) regimen)
Exclusion Criteria
* Patients with a primary diagnosis of a motility disorder (e.g., chronic intestinal pseudo-obstruction) or epithelial cell disorder (e.g., microvillus inclusion disease)
* Malnourished (as defined by Weight/Height Z-score (WHZ) \<-2)
1 Year
17 Years
ALL
No
Sponsors
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Entrinsic Bioscience Inc.
INDUSTRY
Boston Children's Hospital
OTHER
Responsible Party
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Christopher Duggan
Professor of Pediatrics
Principal Investigators
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Christopher P Duggan, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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References
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Freedman SB, Cho D, Boutis K, Stephens D, Schuh S. Assessing the palatability of oral rehydration solutions in school-aged children: a randomized crossover trial. Arch Pediatr Adolesc Med. 2010 Aug;164(8):696-702. doi: 10.1001/archpediatrics.2010.129.
Modi BP, Langer M, Ching YA, Valim C, Waterford SD, Iglesias J, Duro D, Lo C, Jaksic T, Duggan C. Improved survival in a multidisciplinary short bowel syndrome program. J Pediatr Surg. 2008 Jan;43(1):20-4. doi: 10.1016/j.jpedsurg.2007.09.014.
Gosselin 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.
King CK, Glass R, Bresee JS, Duggan C; Centers for Disease Control and Prevention. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep. 2003 Nov 21;52(RR-16):1-16.
Faruque AS, Mahalanabis D, Hamadani J, Hoque SS. Hypo-osmolar sucrose oral rehydration solutions in acute diarrhoea: a pilot study. Acta Paediatr. 1996 Oct;85(10):1247-8. doi: 10.1111/j.1651-2227.1996.tb18240.x.
World Health Organization. Oral rehydration salts (ORS): A new reduced osmolarity formulation. Geneva: WHO, 2002 Contract No.: September 23, 2002.
Santosham M, Burns BA, Reid R, Letson GW, Duncan B, Powlesland JA, Foster S, Garrett S, Croll L, Nyunt Nyunt W, et al. Glycine-based oral rehydration solution: reassessment of safety and efficacy. J Pediatr. 1986 Nov;109(5):795-801. doi: 10.1016/s0022-3476(86)80696-5.
Lima AA, Carvalho GH, Figueiredo AA, Gifoni AR, Soares AM, Silva EA, Guerrant RL. Effects of an alanyl-glutamine-based oral rehydration and nutrition therapy solution on electrolyte and water absorption in a rat model of secretory diarrhea induced by cholera toxin. Nutrition. 2002 Jun;18(6):458-62. doi: 10.1016/s0899-9007(02)00775-x.
Nightingale JM. The Sir David Cuthbertson Medal Lecture. Clinical problems of a short bowel and their treatment. Proc Nutr Soc. 1994 Jul;53(2):373-91. doi: 10.1079/pns19940043. No abstract available.
Lennard-Jones JE. Oral rehydration solutions in short bowel syndrome. Clin Ther. 1990;12 Suppl A:129-37; discussion 138.
Nightingale J, Woodward JM; Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for management of patients with a short bowel. Gut. 2006 Aug;55 Suppl 4(Suppl 4):iv1-12. doi: 10.1136/gut.2006.091108. No abstract available.
Radlovic V, Lekovic Z, Radlovic N, Lukac M, Ristic D, Simic D, Bijelic M. Significance of the application of oral rehydration solution to maintain water and electrolyte balance in infants with ileostomy. Srp Arh Celok Lek. 2013 May-Jun;141(5-6):325-8. doi: 10.2298/sarh1306325r.
Yin L, Gupta R, Vaught L, Grosche A, Okunieff P, Vidyasagar S. An amino acid-based oral rehydration solution (AA-ORS) enhanced intestinal epithelial proliferation in mice exposed to radiation. Sci Rep. 2016 Nov 23;6:37220. doi: 10.1038/srep37220.
Ching YA, Modi BP, Jaksic T, Duggan C. High diagnostic yield of gastrointestinal endoscopy in children with intestinal failure. J Pediatr Surg. 2008 May;43(5):906-10. doi: 10.1016/j.jpedsurg.2007.12.037.
Duro D, Kalish LA, Johnston P, Jaksic T, McCarthy M, Martin C, Dunn JC, Brandt M, Nobuhara KK, Sylvester KG, Moss RL, Duggan C. Risk factors for intestinal failure in infants with necrotizing enterocolitis: a Glaser Pediatric Research Network study. J Pediatr. 2010 Aug;157(2):203-208.e1. doi: 10.1016/j.jpeds.2010.02.023. Epub 2010 May 6.
Hull MA, Jones BA, Zurakowski D, Raphael B, Lo C, Jaksic T, Duggan C. Low serum citrulline concentration correlates with catheter-related bloodstream infections in children with intestinal failure. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):181-7. doi: 10.1177/0148607110381406.
Squires 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.
Khan FA, Squires RH, Litman HJ, Balint J, Carter BA, Fisher JG, Horslen SP, Jaksic T, Kocoshis S, Martinez JA, Mercer D, Rhee S, Rudolph JA, Soden J, Sudan D, Superina RA, Teitelbaum DH, Venick R, Wales PW, Duggan C; Pediatric Intestinal Failure Consortium. Predictors of Enteral Autonomy in Children with Intestinal Failure: A Multicenter Cohort Study. J Pediatr. 2015 Jul;167(1):29-34.e1. doi: 10.1016/j.jpeds.2015.03.040. Epub 2015 Apr 25.
Fullerton BS, Sparks EA, Hall AM, Duggan C, Jaksic T, Modi BP. Enteral autonomy, cirrhosis, and long term transplant-free survival in pediatric intestinal failure patients. J Pediatr Surg. 2016 Jan;51(1):96-100. doi: 10.1016/j.jpedsurg.2015.10.027. Epub 2015 Oct 23.
Fayad IM, Hashem M, Duggan C, Refat M, Bakir M, Fontaine O, Santosham M. Comparative efficacy of rice-based and glucose-based oral rehydration salts plus early reintroduction of food. Lancet. 1993 Sep 25;342(8874):772-5. doi: 10.1016/0140-6736(93)91540-3.
Santosham M, Fayad I, Abu Zikri M, Hussein A, Amponsah A, Duggan C, Hashem M, el Sady N, Abu Zikri M, Fontaine O. A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose. J Pediatr. 1996 Jan;128(1):45-51. doi: 10.1016/s0022-3476(96)70426-2.
Duggan C, Lasche J, McCarty M, Mitchell K, Dershewitz R, Lerman SJ, Higham M, Radzevich A, Kleinman RE. Oral rehydration solution for acute diarrhea prevents subsequent unscheduled follow-up visits. Pediatrics. 1999 Sep;104(3):e29. doi: 10.1542/peds.104.3.e29.
Duggan C, Fontaine O, Pierce NF, Glass RI, Mahalanabis D, Alam NH, Bhan MK, Santosham M. Scientific rationale for a change in the composition of oral rehydration solution. JAMA. 2004 Jun 2;291(21):2628-31. doi: 10.1001/jama.291.21.2628. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Study Documents
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Document Type: Study Protocol
For further details contact Lissette Jimenez, MD Email: [email protected]
View DocumentOther Identifiers
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IRB-P00024854
Identifier Type: -
Identifier Source: org_study_id
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