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

Not Applicable

Terminated

• Conditions: Short Bowel Syndrome
• Interventions: Dietary Supplement: Enterade® oral rehydration solution

• Registration Number: NCT03105362
• Lead Sponsor: Boston Children's Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-07
• Study Start: 2017-08-16
• Primary Completion: 2018-01-20
• Study Completion: 2018-04-03
• Results First Submitted: 2018-05-30
• Results First Submitted QC: 2019-12-16
• Results First Posted: 2019-12-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amino Acid-ORS arm	Enterade® oral rehydration solution	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.

Primary Outcome Measures

Name	Time	Method
Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity	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.
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States