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Summary

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 .

Conditions

Short Bowel Syndrome

Recruitment Status

Terminated

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.

Eligibility Criteria

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)

Intervention

Intervention Type

Intervention Name

Dietary Supplement

Enterade® oral rehydration solution

Phase

Not Applicable

Gender

All

Min Age

1 Year

Max Age

17 Years

Download Date

February 24, 2020

Principal Investigator

Christopher Duggan

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: