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

Boston Children's Hospital4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Short Bowel Syndrome

Interventions

Enterade® oral rehydration solutionDIETARY_SUPPLEMENT

Commercially available amino acid based oral rehydration solution

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Total study duration 14 days

Secondary Outcomes

Tolerance: Reported Episodes of Abdominal Distension and Emesis

Number of episodes reported of abdominal distension and emesis during study period

Time frame: 14 days

Data from ClinicalTrials.gov

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