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

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 .

Full Title of Study: “Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 20, 2018

Detailed Description

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.

Interventions

  • Dietary Supplement: Enterade® oral rehydration solution
    • Commercially available amino acid based oral rehydration solution

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Tolerance: Reported Episodes of Abdominal Distension and Emesis
    • Time Frame: 14 days
    • Number of episodes reported of abdominal distension and emesis during study period

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Children’s Hospital
  • Collaborator
    • Entrinsic Bioscience Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christopher Duggan, Professor of Pediatrics – Boston Children’s Hospital
  • Overall Official(s)
    • Christopher P Duggan, MD, Principal Investigator, Boston Children’s Hospital

References

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