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Trial record 6 of 9 for:    enterade

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

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ClinicalTrials.gov Identifier: NCT03105362
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : January 25, 2018
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)
Estimated Enrollment : 5 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
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AA ORS arm
Patients will consume commercially amino acid based oral rehydration solution (enterade®).
Dietary Supplement: Enterade® oral rehydration solution
Commercially available amino acid based oral rehydration solution




Primary Outcome Measures :
  1. Stool output [ Time Frame: 14 days ]
    Ostomy output measured as milliliters per day (participants who have an ostomy) or frequency (participants who have intestinal continuity).


Secondary Outcome Measures :
  1. Tolerance: Incidence of abdominal distention and emesis [ Time Frame: 14 days ]
    Incidence of abdominal distention and emesis.


Other Outcome Measures:
  1. Palatability on the 100-mm visual analog scale [ Time Frame: 14 days ]
    Rating of enterade® taste compared to previous oral rehydration solution comparing measurements on the 100-mm visual analog scale. The facial hedonic method. (worst (0mm), best taste(100mm)).



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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


Contacts
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Contact: Christopher P Duggan, MD 617-355-7612 Christopher.Duggan@childrens.harvard.edu
Contact: Lissette Jimenez, MD 617-355-4806 Lissette.Jimenez@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Christopher P Duggan, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Entrinsic Health Solutions, Inc.

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     History of Changes
Other Study ID Numbers: IRB-P00024854
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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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