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

February 10, 2020 updated by: Christopher Duggan, Boston Children's Hospital

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 .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amino Acid-ORS arm
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.
Dietary supplement: Enterade® oral rehydration solution
Commercially available amino acid based oral rehydration solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy
Time Frame: 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.
Total study duration14 days
Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity
Time Frame: 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.
Total study duration 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance: Reported Episodes of Abdominal Distension and Emesis
Time Frame: 14 days
Number of episodes reported of abdominal distension and emesis during study period
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS
Time Frame: 14 days
Rating of enterade® taste was compared to previous "patient baseline" oral rehydration solution taste. We compared measurements using the facial hedonic method 100-mm visual analog scale (worst (0mm) and best taste(100mm)). We utilized the difference between two measurements: Day 0 (baseline ORS) and Day 14 (last study day of Amino Acid-ORS consumption). The difference was reported (Day 14 minus value at Day 0).
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Entrinsic Bioscience Inc.

Investigators

  • Principal Investigator: Christopher P Duggan, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2017

Primary Completion (Actual)

January 20, 2018

Study Completion (Actual)

April 3, 2018

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00024854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information comments: For further details contact Lissette Jimenez, MD Email: lissette.jimenez@childrens.harvard.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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