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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:1 - 17
Updated:1/27/2018
Start Date:August 16, 2017
End Date:October 2018
Contact:Christopher P Duggan, MD
Email:Christopher.Duggan@childrens.harvard.edu
Phone:617-355-7612

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

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.

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)
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Christopher P Duggan, MD
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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mi
from
Boston, MA
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