Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Change in Gastrointestinal Quality of Life Index (GIQLI) Score
研究概览
简要总结
This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.
详细描述
This prospective, non-randomized, open-label study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption. Adults with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were enrolled in the study and asked to take the study product for 6 weeks. The primary measure of the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency Questionnaire (DSFQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index 19 - 40 kg/m2
- •Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease
排除标准
- •Gastroenterologic surgery within 3 months before the study period
- •Have a colostomy or ileostomy bag
- •Malignancy within the last 5 years
- •Women who are lactating, pregnant or planning pregnancy during the study period
- •Taking antibiotic, antiparasitic, or antifungal medications
- •Initiation of or changes to supplements or medications within 28 days prior to screening
结局指标
主要结局
Change in Gastrointestinal Quality of Life Index (GIQLI) Score
时间窗: 6 weeks
次要结局
- Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score(6 weeks)
- Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score(6 weeks)
- Change in Celiac Disease Questionnaire (CDQ) Score(6 weeks)