Comparison of Different Oral Rehydration Solutions

Study Overview
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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.

Official Title
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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.

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: WHO ORS
* Dietary Supplement: Commercial ORS


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WHO ORS<br>Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day. | Dietary Supplement: WHO ORS<br>* 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.<br>* Other names: World Health Organization ORS;|
| Active Comparator: Commercial ORS<br>Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day. | Dietary Supplement: Commercial ORS<br>* Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.<br>* Other names: Dripdrop;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Parenteral Nutrition, Compliance, Short Bowel Syndrome, Oral Rehydration Solution