Back to resultsComparison of Different Oral Rehydration Solutions (ORS)
Primary Purpose
Short Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WHO ORS
Commercial ORS
Sponsored by
About this trial
This is an interventional supportive care trial for Short Bowel Syndrome focused on measuring Home Parenteral Nutrition, Compliance, Short Bowel Syndrome, Oral Rehydration Solution
Eligibility Criteria
Inclusion Criteria
- All patients with short bowel syndrome treated by the HPN program.
Exclusion Criteria
- Participants who have do not provide written consent.
- Participants who lack the ability to provide informed consent
- Participants who are not anticipated to be on HPN for at least 6 months (determined by PrincipaI Investigator).
- Pregnant women
- Participants with pre-existing congestive heart failure, acute/ chronic kidney failure. (determined by the PrincipaI Investigator)
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
WHO ORS
Commercial ORS
Arm Description
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Outcomes
Primary Outcome Measures
Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS.
Secondary Outcome Measures
Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02142582
Brief Title
Comparison of Different Oral Rehydration Solutions
Acronym
ORS
Official Title
Comparison of Different Oral Rehydration Solutions (ORS) in Short Bowel Syndrome (SBS) Patients on Home Parenteral Nutrition (HPN): A Prospective Double-blinded Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid loss due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these patients. The investigators believe that taste of the standard ORS is the biggest reason why these patients are not complaint. The new ORS in the market has been prepared with this in mind. The investigators want to study if this new ORS will improve the compliance in this patient cohort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Home Parenteral Nutrition, Compliance, Short Bowel Syndrome, Oral Rehydration Solution
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WHO ORS
Arm Type
Active Comparator
Arm Description
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Arm Title
Commercial ORS
Arm Type
Active Comparator
Arm Description
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Intervention Type
Dietary Supplement
Intervention Name(s)
WHO ORS
Other Intervention Name(s)
World Health Organization ORS
Intervention Description
Participants will be randomized into one of the two groups. They will be provided with one of the two ORS solutions. Then, they will be followed for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Commercial ORS
Other Intervention Name(s)
Dripdrop
Intervention Description
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Primary Outcome Measure Information:
Title
Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
All patients with short bowel syndrome treated by the HPN program.
Exclusion Criteria
Participants who have do not provide written consent.
Participants who lack the ability to provide informed consent
Participants who are not anticipated to be on HPN for at least 6 months (determined by PrincipaI Investigator).
Pregnant women
Participants with pre-existing congestive heart failure, acute/ chronic kidney failure. (determined by the PrincipaI Investigator)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Hurt, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Comparison of Different Oral Rehydration Solutions
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