Short Bowel SyndromeORSNCT02142582
Comparison of Different Oral Rehydration Solutions
A study testing WHO ORS and Commercial ORS in people with Short Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- WHO ORS and Commercial ORS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with short bowel syndrome treated by the HPN program.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official 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.
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.
- Conditions
- Short Bowel Syndrome
- Being tested
- WHO ORS, Commercial ORS
- Keywords
- Home Parenteral Nutrition, Compliance, Short Bowel Syndrome, Oral Rehydration Solution
- Medical subject headings
- Short Bowel Syndrome, Patient Compliance, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO ORSDietary supplement
Also called World Health Organization 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.
Commercial ORSDietary supplement
Also called Dripdrop
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
| Study group | Role | What they receive |
|---|---|---|
| WHO ORS | Active comparator | Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day. Receives: Dietary Supplement: WHO ORS |
| Commercial ORS | Active comparator | Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day. Receives: Dietary Supplement: Commercial ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS.
Measured: 6 months
Secondary outcomes (1)
Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan T. Hurt, M.D., Ph.D., Mayo Clinic
- Investigators
- Ryan Hurt, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142582
- Sponsor's protocol ID
- 13-008346
- Acronym
- ORS
- Status last verified
- May 2016
- First submitted
- 16 May 2014
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02142582
- Acronym / sponsor ID
- ORS / 13-008346
- Conditions
- Short Bowel Syndrome
- Keywords
- Home Parenteral Nutrition, Compliance, Short Bowel Syndrome, Oral Rehydration Solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO ORS | Active comparator | Dietary Supplement: WHO ORSParticipants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day. |
| Commercial ORS | Active comparator | Dietary Supplement: Commercial ORSParticipants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with short bowel syndrome treated by the HPN program.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO ORSAlso: World Health Organization ORSParticipants 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 supplement | WHO ORS |
| Commercial ORSAlso: DripdropParticipants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day. | Dietary supplement | Commercial ORS |
Primary outcome
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
1 secondary outcome
Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Hurt, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO ORS and Commercial ORS in people with Short Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.