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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Enterade® oral rehydration solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Open label single center pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amino Acid-ORS arm<br>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<br>* Commercially available amino acid based oral rehydration solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Rehydration Solutions