Effects of an Amino Acid Mixture Versus a Sugar Based Sports Drink on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- GI output
研究概览
简要总结
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches. Findings from this study and possible future studies could have broad implications for patients with malabsorption resulting from many underlying conditions, including IBD.
详细描述
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches. Findings from this study and possible future studies could have broad implications for patients with malabsorption resulting from many underlying conditions, including IBD.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Single (physician) blinded.
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
- •Colectomy with ileostomy
- •a. Ileostomy alone with less than 30 cm of small bowel resected i. A diverting ileostomy is permitted
- •Stable disease activity with no or mild inflammation felt not to significantly impact gastrointestinal (GI) output.
- •Any of the following:
- •Need for IV fluids >2x/month
- •Intake of > 1.5 liters of oral fluid daily
- •GI output of > 1.3 liters in a 24-hour period for three days each week during a 14 day screening period (does not need to be consecutive days)
- •Stable doses of anti-diarrheal agents, octreotide or Gattex
- •Stable doses of anti-inflammatory agents and/or antibiotics
- •Willing to comply with study visits and assessments, including product intake.
排除标准
- •Chronic renal insufficiency glomerular filtration rate (GFR) < 40
- •Significant chronic liver disease altering fluid balance
- •Uncontrolled flare of inflammatory disease
- •a. (Inflammation can be present but at a stable at least partly controlled level) b. An anticipated change in medication in the next 3 months i. May be included 8 weeks after changing medications if they are stable c. Anticipated gastrointestinal surgery in the subsequent 3 months i. May be included if they are 4 months out from surgery and stable
- •Use of Lactulose/Mannitol solution is contraindicated
- •Current Diagnosis of Cancer
- •a. May be included if they are 4 or more months out from cancer therapy (i.e. chemotherapy, etc.)
- •Aversion to the taste of enterade® or inability to take the product as instructed
结局指标
主要结局
GI output
时间窗: total 8 weeks
Change in GI output over a 24 hour period as the average of the 3 days every week for two different periods of 4 weeks
次要结局
- Fluid Balance(8 weeks)
- Immune Response based on Cytokine Levels(8 weeks)
- Changes in heart rate(8 weeks)
- Changes in Blood(8 weeks)
- Changes in Lactulose-Mannitol Test(8 weeks)
- Tolerability of Drink(8 weeks)
- Quality of Life Index(8 weeks)