Clinical trial NCT03105362: Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
Official title: Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Short Bowel Syndrome
Keywords: Oral Rehydration Solutions
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Entrinsic Bioscience Inc.
First posted: 2017-04-07
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single center pilot study
Primary purpose: SUPPORTIVE_CARE

Brief 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 .

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)

Primary outcomes:
measure: Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy
timeFrame: Total study duration14 days
measure: Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity
timeFrame: Total study duration 14 days
Secondary outcomes:
measure: Tolerance: Reported Episodes of Abdominal Distension and Emesis
timeFrame: 14 days
Other outcomes:
measure: Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS
timeFrame: 14 days
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christopher P Duggan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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