Comparison of Different Oral Rehydration Solutions

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02142582

Acronym

ORS

Enrollment

Registered

2014-05-20

Start date

2014-05-31

Completion date

2016-04-30

Last updated

2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

Keywords

Home Parenteral Nutrition, Compliance, Short Bowel Syndrome, Oral Rehydration Solution

Brief 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.

Interventions

DIETARY_SUPPLEMENTWHO 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.

DIETARY_SUPPLEMENTCommercial ORS

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

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.	6 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026