Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT03105362|
Recruitment Status : Terminated (Issues w/ sponsor and recruitment)
First Posted : April 7, 2017
Results First Posted : December 17, 2019
Last Update Posted : February 24, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome||Dietary Supplement: Enterade® oral rehydration solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label single center pilot study|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome|
|Actual Study Start Date :||August 16, 2017|
|Actual Primary Completion Date :||January 20, 2018|
|Actual Study Completion Date :||April 3, 2018|
Experimental: 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.
Dietary Supplement: Enterade® oral rehydration solution
Commercially available amino acid based oral rehydration solution
- Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy [ Time Frame: Total study duration14 days ]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.
- Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity [ Time Frame: Total study duration 14 days ]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.
- Tolerance: Reported Episodes of Abdominal Distension and Emesis [ Time Frame: 14 days ]Number of episodes reported of abdominal distension and emesis during study period
- Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS [ Time Frame: 14 days ]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).
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|Ages Eligible for Study:||1 Year to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- Patients receiving IV antibiotics within the previous 72h.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105362
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Christopher P Duggan, MD||Boston Children's Hospital|
Documents provided by Christopher Duggan, Boston Children's Hospital:
|Responsible Party:||Christopher Duggan, Professor of Pediatrics, Boston Children's Hospital|
|Other Study ID Numbers:||
|First Posted:||April 7, 2017 Key Record Dates|
|Results First Posted:||December 17, 2019|
|Last Update Posted:||February 24, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Oral Rehydration Solutions
Short Bowel Syndrome
Digestive System Diseases