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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with short bowel syndrome treated by the HPN program.
排除标准
- •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)
研究组 & 干预措施
WHO ORS
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
干预措施: WHO ORS (Dietary Supplement)
Commercial ORS
Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
干预措施: Commercial ORS (Dietary Supplement)
结局指标
主要结局
Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS.
时间窗: 6 months
次要结局
- Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS(Baseline to 6 months)