Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE March 24, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE August 16, 2017
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • 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).
  • Tolerance: Incidence of abdominal distention and emesis [ Time Frame: 14 days ]
    Incidence of abdominal distention and emesis.
Change History Complete list of historical versions of study NCT03105362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
Tolerance: Incidence of abdominal distention and emesis [ Time Frame: 14 days ]
Incidence of abdominal distention and emesis.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
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)).
Current Other Pre-specified Outcome Measures
 (submitted: April 7, 2017)
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)).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
Official Title  ICMJE Tolerability of an Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Open label single center pilot study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Short Bowel Syndrome
Intervention  ICMJE Dietary Supplement: Enterade® oral rehydration solution
Commercially available amino acid based oral rehydration solution
Study Arms  ICMJE Experimental: AA ORS arm
Patients will consume commercially amino acid based oral rehydration solution (enterade®).
Intervention: Dietary Supplement: Enterade® oral rehydration solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2017)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03105362
Other Study ID Numbers  ICMJE IRB-P00024854
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Duggan, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Entrinsic Health Solutions, Inc.
Investigators  ICMJE Not Provided
PRS Account Boston Children’s Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP