Comparison of Different Oral Rehydration Solutions

Short Bowel Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142582
• Other study ID #: 13-008346
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: May 3, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Short Bowel Syndrome

Intervention

Dietary Supplement:
• WHO ORS
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.
• Commercial ORS
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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