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| Name | Class |
|---|---|
| Entrinsic Bioscience Inc. | INDUSTRY |
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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 .
Patients with short bowel syndrome (SBS) have a critical reduction of the gut mass/function that is below the minimum needed to absorb nutrients and fluids required for adequate homeostasis. There are limited data regarding the optimal choice for oral rehydration in the setting of SBS that can maximize fluid absorption in the setting of diarrhea with limited intestinal absorptive surface area. The investigators propose a preliminary open label single center study assessing tolerability and palatability of enterade® ( an amino acid (AA) based oral rehydrating solution (ORS)) and compare to baseline. Eligible patients with SBS will participate in a 14-day trial monitoring and measuring tolerability and palatability of an AA-ORS, enterade®, in addition to their regular diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterade® oral rehydration solution | Dietary Supplement | Commercially available amino acid based oral rehydration solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance: Reported Episodes of Abdominal Distension and Emesis | Number of episodes reported of abdominal distension and emesis during study period | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS | Rating of enterade® taste was compared to previous "patient baseline" oral rehydration solution taste. We compared measurements using the facial hedonic method 100-mm visual analog scale (worst (0mm) and best taste(100mm)). We utilized the difference between two measurements: Day 0 (baseline ORS) and Day 14 (last study day of Amino Acid-ORS consumption). The difference was reported (Day 14 minus value at Day 0). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher P Duggan, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20679159 | Background | 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. | |
| 18206449 | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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No run-in or wash out period prior to participating in study.
Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease), who were on a stable enteral nutrition regimen (oral rehydration fluids taken orally) between the ages of 1-17 were recruited from clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | AA ORS Arm | Patients consumed (orally) an amino acid (AA) based oral rehydration solution (ORS) (enterade®) for 2 weeks as part of their baseline enteral hydration needs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AA ORS Arm | Patients will consume commercially amino acid based oral rehydration solution (enterade®). Enterade® oral rehydration solution: Commercially available amino acid based oral rehydration solution |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants consumed amino acid-based ORS (enterade) | Posted | Mean | Full Range | mL/day | Total study duration14 days |
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Data monitoring for adverse events were collected for 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AA ORS Arm | Participants consuming enterade (amino acid-oral rehydration solution) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Duggan | Boston Children's Hospital | 617-355-7612 | christopher.duggan@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2017 | Apr 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Open label single center pilot study
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| 14 days |
| 25242686 | 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. |
| 14627948 | 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. |
| 8922094 | 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. |
| Background | World Health Organization. Oral rehydration salts (ORS): A new reduced osmolarity formulation. Geneva: WHO, 2002 Contract No.: September 23, 2002. |
| 3534198 | 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. |
| 12044816 | 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. |
| 7972152 | 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. |
| 2187606 | Background | Lennard-Jones JE. Oral rehydration solutions in short bowel syndrome. Clin Ther. 1990;12 Suppl A:129-37; discussion 138. |
| 16837533 | 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. |
| 23858801 | 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. |
| 27876791 | 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. |
| 18485964 | 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. |
| 20447649 | 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. |
| 21378247 | 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. |
| 22578586 | 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. |
| 25917765 | 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. |
| 26561248 | 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. |
| 8103876 | 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. |
| 8551420 | 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. |
| 10469812 | 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. |
| 15173155 | 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. |
For further details contact Lissette Jimenez, MD Email: lissette.jimenez@childrens.harvard.edu |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary Short Bowel Syndrome Diagnosis | Participant's primary medical diagnosis that led to diagnosis of Short Bowel Syndrome | Count of Participants | Participants |
|
| Residual Small Bowel Length | One study participant had an unknown bowel length | Mean | Full Range | centimeters (cm) |
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| Presence of ileostomy or jejunostomy | Count of Participants | Participants |
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| Secondary | Tolerance: Reported Episodes of Abdominal Distension and Emesis | Number of episodes reported of abdominal distension and emesis during study period | Participants consuming amino acid oral rehydration solution (enterade) | Posted | Number | Episodes | 14 days |
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| Other Pre-specified | Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS | Rating of enterade® taste was compared to previous "patient baseline" oral rehydration solution taste. We compared measurements using the facial hedonic method 100-mm visual analog scale (worst (0mm) and best taste(100mm)). We utilized the difference between two measurements: Day 0 (baseline ORS) and Day 14 (last study day of Amino Acid-ORS consumption). The difference was reported (Day 14 minus value at Day 0). | Participants consuming enterade (amino acid oral rehydration solution) | Posted | Mean | Full Range | mm | 14 days |
|
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| Primary | 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. | Participants consumed amino acid-based ORS (enterade) | Posted | Mean | Full Range | Stools per day | Total study duration 14 days |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |