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

Primary Purpose

Short Bowel Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Enterade® oral rehydration solution

About this trial

This is an interventional supportive care trial for Short Bowel Syndrome focused on measuring Oral Rehydration Solutions

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept 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)

Sites / Locations

Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amino Acid-ORS arm

Arm 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.

Outcomes

Primary Outcome Measures

Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy

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.

Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity

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.

Secondary Outcome Measures

Tolerance: Reported Episodes of Abdominal Distension and Emesis

Number of episodes reported of abdominal distension and emesis during study period

Full Information

NCT ID

NCT03105362

First Posted

March 24, 2017

Last Updated

February 10, 2020

Sponsor

Boston Children's Hospital

Collaborators

Entrinsic Bioscience Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03105362

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

Issues w/ sponsor and recruitment

Study Start Date

August 16, 2017 (Actual)

Primary Completion Date

January 20, 2018 (Actual)

Study Completion Date

April 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

Collaborators

Entrinsic Bioscience Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Short Bowel Syndrome

Keywords

Oral Rehydration Solutions

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open label single center pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amino Acid-ORS arm

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Enterade® oral rehydration solution

Intervention Description

Commercially available amino acid based oral rehydration solution

Primary Outcome Measure Information:

Title

Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy

Description

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.

Time Frame

Total study duration14 days

Title

Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity

Description

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.

Time Frame

Total study duration 14 days

Secondary Outcome Measure Information:

Title

Tolerance: Reported Episodes of Abdominal Distension and Emesis

Description

Number of episodes reported of abdominal distension and emesis during study period

Time Frame

14 days

Other Pre-specified Outcome Measures:

Title

Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS

Description

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).

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher P Duggan, MD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

http://www.childrenshospital.org/research-and-innovation/research/research-administration/office-of-clinical-investigation

Available IPD/Information Comments

For further details contact Lissette Jimenez, MD Email: lissette.jimenez@childrens.harvard.edu

Learn more about this trial

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

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