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

Boston Children's Hospital

Status: Terminated

Conditions: Short Bowel Syndrome

Treatments: Dietary Supplement: Enterade® oral rehydration solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03105362

IRB-P00024854

Details and patient eligibility

About

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 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.

Enrollment: 4 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Amino Acid-ORS arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Enterade® oral rehydration solution