Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Carbohydrate Malabsorption
研究概览
简要总结
Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parenteral nutrition intravenously. Therefore, patients with these conditions may not be able to digest sucrose (sugar) fully. Patients might experience abdominal distension/pain, vomiting and diarrhea when sugar is taken in orally or through the g-tube, which can limit patients' ability to increase oral or g-tube feeds in short gut syndrome patients with intestinal failure.
In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Short bowel syndrome, of all ages, with dependence on parental support to provide at least 50% of fluid or caloric needs.
- •Must be on diet containing sucrose.
- •Must be willing and able to sign informed consent
- •Adult and Pediatric patients (all ages)
排除标准
- •Current IV antibiotic administration for confirmed bout of bacteremia.
- •No enteral nutrition
- •Any condition, disease, illness, or circumstance that in the investigator's opinion puts the subject at any undue risk, prevents completion of the study, or interferes with analysis of the study results
研究组 & 干预措施
Sucrase intervention followed by placebo
Participants in this arm will receive sucrase for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of placebo.
干预措施: Sucrase (Drug)
Sucrase intervention followed by placebo
Participants in this arm will receive sucrase for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of placebo.
干预措施: Placebo (Other)
Placebo followed by sucrase intervention
Participants in this arm will receive placebo for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of sucrase.
干预措施: Sucrase (Drug)
Placebo followed by sucrase intervention
Participants in this arm will receive placebo for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of sucrase.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Carbohydrate Malabsorption
时间窗: baseline, 9 weeks
Degree of carbohydrate malabsorption will be assessed by decrease in number of stools per day.
Change in Carbohydrate Malabsorption as Measured by Patient Symptom Survey
时间窗: baseline, 9 weeks
Degree of carbohydrate malabsorption will be assessed by change in patient symptomatology by change in score on patient symptom survey. The survey has range from 0-52 with higher score being worse symptoms and lower being better.
Change in Carbohydrate Malabsorption as Measured by Growth Velocity
时间窗: baseline, 9 weeks
Carbohydrate malabsorption will be measured by increase in growth velocity in kg/week
Change in Carbohydrate Malabsorption as Measured by Enteral Nutrition Tolerance
时间窗: baseline, 9 weeks
Carbohydrate malabsorption will be measured by ability to advance enteral nutrition in ml/day
次要结局
- Change in Digestion(baseline, 9 weeks)
- Change in Digestion as Measured by Amount of Emesis(baseline, 9 weeks)
- Change in Digestion as Measured by Stool Consistency(baseline, 9 weeks)