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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03105362
Recruitment Status : Terminated (Issues w/ sponsor and recruitment)
First Posted : April 7, 2017
Results First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
Entrinsic Health Solutions, Inc.
Information provided by (Responsible Party):
Christopher Duggan, 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 .

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Dietary Supplement: Enterade® oral rehydration solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label single center pilot study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : April 3, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Tolerance: Reported Episodes of Abdominal Distension and Emesis [ Time Frame: 14 days ]
    Number of episodes reported of abdominal distension and emesis during study period


Other Outcome Measures:
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105362


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Entrinsic Health Solutions, Inc.
Investigators
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Principal Investigator: Christopher P Duggan, MD Boston Children’s Hospital
  Study Documents (Full-Text)

Documents provided by Christopher Duggan, Boston Children’s Hospital:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
For further details contact Lissette Jimenez, MD Email: lissette.jimenez@childrens.harvard.edu

Publications:
World Health Organization. Oral rehydration salts (ORS): A new reduced osmolarity formulation. Geneva: WHO, 2002 Contract No.: September 23, 2002.

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Responsible Party: Christopher Duggan, Professor of Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03105362    
Other Study ID Numbers: IRB-P00024854
First Posted: April 7, 2017    Key Record Dates
Results First Posted: December 17, 2019
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Duggan, Boston Children’s Hospital:
Oral Rehydration Solutions
Additional relevant MeSH terms:
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Short Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pharmaceutical Solutions