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
|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome||Dietary Supplement: Enterade® oral rehydration solution||Not Applicable|
|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|
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
- 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.
- 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)).
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
|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|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Christopher P Duggan, MD|