Short Bowel Syndrome Clinical Trial
— ORSOfficial 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.
Verified date | May 2016 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS. | 6 months | No | |
Secondary | Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS | Baseline to 6 months | No |
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