Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome

NCT03105362 | Terminated Results

• 1 other identifier: IRB-P00024854
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .

Conditions

Short Bowel Syndrome

Keywords

Oral Rehydration Solutions

Outcome Measures

Primary Outcomes (2)

• Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy

  Ostomy output measured as milliliters per day. The mean of outputs where compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.

  Total study duration14 days

• Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity

  Output was measured as frequency of stools per day. The mean output was compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.

  Total study duration 14 days

Secondary Outcomes (1)

• Tolerance: Reported Episodes of Abdominal Distension and Emesis

  14 days

Other Outcomes (1)

• Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS

  14 days

Study Arms (1)

Amino Acid-ORS arm

EXPERIMENTAL

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.

Dietary Supplement: Enterade® oral rehydration solution

Interventions

Enterade® oral rehydration solution DIETARY_SUPPLEMENT

Commercially available amino acid based oral rehydration solution

Amino Acid-ORS arm

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease) between the ages of 1-17
• 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)

You may not qualify if:

• Patients receiving IV antibiotics within the previous 72h.
• Malnourished (as defined by Weight/Height Z-score (WHZ) \<-2)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Entrinsic Bioscience Inc.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (23)

• 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.

  PMID: 20679159 BACKGROUND

• 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.

  PMID: 18206449 BACKGROUND

• 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.

  PMID: 25242686 BACKGROUND

• 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.

  PMID: 14627948 BACKGROUND

• 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.

  PMID: 8922094 BACKGROUND

• World Health Organization. Oral rehydration salts (ORS): A new reduced osmolarity formulation. Geneva: WHO, 2002 Contract No.: September 23, 2002.

  BACKGROUND

• 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.

  PMID: 3534198 BACKGROUND

• 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.

  PMID: 12044816 BACKGROUND

• 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.

  PMID: 7972152 BACKGROUND

• Lennard-Jones JE. Oral rehydration solutions in short bowel syndrome. Clin Ther. 1990;12 Suppl A:129-37; discussion 138.

  PMID: 2187606 BACKGROUND

• 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.

  PMID: 16837533 BACKGROUND

• 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.

  PMID: 23858801 BACKGROUND

• 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.

  PMID: 27876791 BACKGROUND

• 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.

  PMID: 18485964 BACKGROUND

• 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.

  PMID: 20447649 BACKGROUND

• 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.

  PMID: 21378247 BACKGROUND

• 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.

  PMID: 22578586 BACKGROUND

• 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.

  PMID: 25917765 BACKGROUND

• 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.

  PMID: 26561248 BACKGROUND

• 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.

  PMID: 8103876 BACKGROUND

• 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.

  PMID: 8551420 BACKGROUND

• 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.

  PMID: 10469812 BACKGROUND

• 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.

  PMID: 15173155 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Christopher Duggan
• Organization: Boston Children's Hospital

christopher.duggan@childrens.harvard.edu

617-355-7612

Study Officials

• Christopher P Duggan, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Open label single center pilot study

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 7, 2017
• Study Start: August 16, 2017
• Primary Completion: January 20, 2018
• Study Completion: April 3, 2018
• Last Updated: February 24, 2020
• Results First Posted: December 17, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)