Clinical, Biochemical, and Microbiological Effects of Constipation Treatment in Patients With Chronic Kidney Disease: A Pilot Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol
研究概览
简要总结
Constipation is one of the most prevalent gastrointestinal disorders in patients with chronic kidney disease (CKD) and has been associated with their adverse kidney and cardiovascular outcomes; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical and microbiological parameters in patients with CKD. The investigators aim to test the feasibility of delivering an intervention with constipation treatment and determine its effects on changes in clinical, biochemical, and microbiological parameters in patients with CKD and constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients >18 years old.
- •Patients able and willing to provide written informed consent and HIPAA authorization.
- •CKD stages G3-G5 without kidney replacement therapy with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 creatinine equation.
- •Functional or opioid-induced constipation based on the Rome IV criteria.
- •Patients must refrain from taking any laxatives for at least one week prior to screening, although rescue with one bisacodyl 5 mg tablet will be allowed when a patient does not have a bowel movement for ≥3 consecutive days or when symptoms become intolerable.
- •A negative pregnancy test in female patients prior to enrolment, unless the patient is two years postmenopausal or has had a documented tubal ligation or hysterectomy.
排除标准
- •History of drug abuse, anorexia nervosa, or bulimia.
- •History of irritable bowel syndrome, inflammatory bowel disease, or Clostridium difficile bacterial infection (ever).
- •Liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included).
- •Galactosemia.
- •Allergies to lactulose.
- •History of gastrointestinal surgery except appendectomy.
- •Use of antibiotics or immunosuppressants within 30 days prior to the enrollment in the study.
- •Use of pre- or probiotics within 30 days prior to enrollment in the study.
- •Women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding.
- •Patients currently participating in another interventional study.
- •Major surgery within one month prior to enrollment in the study or planned surgery while the patient is in the study, other than dialysis vascular access surgery.
- •Patients who the investigator determine have a medical status that would preclude the patient's participation.
- •Patients on hemodialysis or peritoneal dialysis.
- •Patients with a functional kidney transplant.
- •Patients with past lactulose use.
结局指标
主要结局
The feasibility of delivering the proposed interventions and performing the proposed examinations, assessed based on the adherence to prescribed protocol
时间窗: From enrollment to the end of follow-up at 6 weeks
The feasibility of delivering the applied interventions and performing the proposed examinations will be determined based on the following feasibility outcomes, assessed as 1) ≥90% of participants randomized in the intervention group and under observation will adhere to the proposed intervention, 2) ≥80% patients under observation will adhere to the study-specific timed collection of stool, urine, and blood samples, and 3) ≥85% patients will complete the study (\<15% patients will be dropped out).
次要结局
- Changes in serum phosphorus(From enrollment to the end of follow-up at 6 weeks)
- Changes in serum creatinine(From enrollment to the end of follow-up at 6 weeks)
- Changes in serum p-cresyl sulfate and indoxyl sulfate(From enrollment to the end of follow-up at 6 weeks)
- Changes in plasma potassium(From enrollment to the end of follow-up at 6 weeks)
- Changes in plasma C-reactive protein(From enrollment to the end of follow-up at 6 weeks)
- Changes in microbial parameters(From enrollment to the end of follow-up at 6 weeks)
- Changes in stool consistency(From enrollment to the end of follow-up at 6 weeks)
- Changes in plasma lipopolysaccharide(From enrollment to the end of follow-up at 6 weeks)
- Changes in urine albumin-creatinine ratio (UACR) and protein-creatinine ratio (UPCR)(From enrollment to the end of follow-up at 6 weeks)
- Changes in constipation symptoms(From enrollment to the end of follow-up at 6 weeks)