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Comparison of Different Oral Rehydration Solutions (ORS)

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Mayo Clinic

Status

Completed

Conditions

Short Bowel Syndrome

Treatments

Dietary Supplement: WHO ORS
Dietary Supplement: Commercial ORS

Study type

Interventional

Funder types

Other

Identifiers

NCT02142582
13-008346

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

28 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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