Comparison of Different Oral Rehydration Solutions

NCT ID: NCT02142582

Last Updated: 2016-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Short Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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WHO ORS

Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.

Group Type ACTIVE_COMPARATOR

WHO ORS

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type ACTIVE_COMPARATOR

Commercial ORS

Intervention Type DIETARY_SUPPLEMENT

Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Commercial ORS

Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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World Health Organization ORS Dripdrop

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ryan T. Hurt, M.D., Ph.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Hurt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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13-008346

Identifier Type: -

Identifier Source: org_study_id

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