Comparison of Different Oral Rehydration Solutions (ORS)

May 3, 2016 updated by: Ryan T. Hurt, M.D., Ph.D., Mayo Clinic

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: WHO ORS
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
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.
Other Names:
  • World Health Organization ORS
Active Comparator: Commercial ORS
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Dietary supplement: Commercial ORS
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Other Names:
  • Dripdrop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS
Time Frame: Baseline to 6 months
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ryan Hurt, MD, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-008346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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