Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 24-hour fecal wet weight
研究概览
简要总结
Clinical trial, active comparator, cross over, randomised. In total, 12 adults with an ileostomy will be randomised to a sequential 4 weeks intervention with different qualities and sources of protein wish 2-week washout periods. Primary outcome: Ileostomy output.
详细描述
Patients with an ileostomy may be dehydrated and have nutritional deficiencies secondary to malabsorption of fluid, electrolytes, and nutrients. In this randomised, double blinded, crossover intervention study we aim to investigate how different protein sources affect intestinal absorption in patients with an ileostomy and intestinal insufficiency. Three oral solutions with different protein sources (hydrolysed whey, whey, and casein) will be administered in three different four-week intervention periods. The results will facilitate improved counselling and treatment of patients with an ileostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Production in separate facility, randomisation key kept by third party
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥ 18 years old), male or female patients with an ileostomy and intestinal insufficiency
- •Episodical or chronic sodium depletion defined by two urine samples with sodium levels ≤ 20 mmol/L, sampled with at least 28 days apart
- •Six months or more after most recent bowel surgery
- •If inflammatory bowel disease, no clinical signs of activity (any treatment allowed except systemic steroids > 10 mg/day)
排除标准
- •Parenteral nutrition or intravenous fluid support ≥ 4000 mL/month
- •Ongoing infection (C-reactive protein above 8 mg/L or core temperature >38.0°C)
- •Self-reported intolerance to dairy products, including lactose intolerance
- •Inability to understand Danish or the trial procedures
- •Known or anticipated pregnancy
- •Known severe renal insufficiency (eGFR < 20 mL/min)
- •Known diabetes mellitus (HbA1c ≥ 48 mmol/mol (6.5%))
- •Pacemaker, cochlear implants, or other electrical implants excludes the participants from BIA-measurements and measurements of GITT with 3D-Transit capsules, but not the remaining investigations
- •Known intestinal stenosis or parastomal hernia excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
- •Abdominal diameter > 140 cm, or planned MR scan four weeks following participation excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
研究组 & 干预措施
Hydrolysed whey
Hydrolysed whey
干预措施: Hydrolysed whey (Dietary Supplement)
Intact whey
Intact whey
干预措施: Intact whey (Dietary Supplement)
Caseinate
Caseinate
干预措施: Caseinate (Dietary Supplement)
结局指标
主要结局
24-hour fecal wet weight
时间窗: 4 weeks
Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period
次要结局
- Total body water (L)(4 weeks)
- Physical activity(4 weeks)
- Body weight (kg)(4 weeks)
- Amino acid absorption(6 hours)
- GLP1 and GLP2(6 hours)
- Portosystemic hepatic encephalopathy (PSE) test score, median value(4 weeks)
- Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)(4 weeks)
- Diuresis(4 weeks)
- Natriuresis(4 weeks)
- Gastric and small bowel emptying(6 hours)
- Continuous reaction time (CRT) index median(4 weeks)
- Extracellular water (L)(4 weeks)
- Skeletal muscle mass (kg)(4 weeks)
- Fat mass (kg)(4 weeks)
- Fat-free mass (kg)(4 weeks)
研究者
Christian Hvas
Consultant, associate professor
Aarhus University Hospital