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OpenTrials
Completed

NCT Number: NCT02142582

Comparison of Different Oral Rehydration Solutions

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.

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Key information

Conditions

Short Bowel Syndrome Arthritis Behavior Digestive System Diseases Gastrointestinal Diseases Health Behavior Intestinal Diseases Joint Diseases Malabsorption Syndromes Musculoskeletal Diseases Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Postoperative Complications Rheumatic Diseases Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WHO ORS

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.

Other names: World Health Organization ORS

Commercial ORS

Dietary Supplement

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

Other names: Dripdrop

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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.

Acronym: ORS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 20, 2014
Registry last updated
May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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