Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Number of Participants With a 50 Percent Decrease in Mean Stool Count
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the drug Crofelemer in the treatment of non-HIV patients with chronic idiopathic diarrhea; to determine the prevalence of identifiable causes of chronic diarrhea in a non-HIV patients; to assess the diagnostic yield, in terms of identification of treatable etiologies, of commercially available diagnostic evaluations in adult, non-HIV patients with chronic idiopathic diarrhea, that is, evaluate which tests, among the standard diagnostic tests commonly conducted as part of the evaluation of chronic idiopathic diarrhea, are most likely to identify a treatable cause of the diarrhea; and to analyze the relationship between chronic idiopathic diarrhea and health-related quality of life and assess the impact of crofelemer treatment on health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic diarrhea (defined as 3 non-bloody loose stools per day or more than 20 non-bloody loose stools per week for more ≥ 4 weeks) and Bristol Stool Form Scale for stool consistency of 6/7 with >50% stool without an obvious cause after evaluation for organic etiologies.
- •Patients from any ethnicity
排除标准
- •Hematochezia (potentially related to an organic cause).
- •Subjects less than 18 years of age more than 75 years of age (safety and effectiveness of crofelemer has not been established in these age groups).
- •Pregnant females (crofelemer is a Category C drug due to lack of well-controlled studies to study its effects in this population).
- •Lactating females (it is unknown if crofelemer is excreted in the human milk and thus may have unknown adverse effects on the nursing infants).
- •HIV positive individuals.
- •Persons within ability to provide consent and understand the study
- •Persons with history of alcohol abuse or binge drinking.
- •Persons with history of surgical bowel resection or bariatric surgery in the past 12 months.
- •Persons who have undergone cholecystectomy (open or laparoscopic) in the past 3 months.
- •Persons receiving antibiotics currently or have received antimicrobials in the past 4 weeks.
- •Persons with end-organ failures including end-stage renal disease, end-stage liver disease, or severe heart failure.
- •Persons with metastatic hematologic and oncologic malignancies.
- •Persons receiving chemo-radiation or immune-modulators for oncologic or rheumatologic conditions.
- •Persons with any other known organic gastrointestinal or non-gastrointestinal disease process in which diarrhea is a recognized clinical feature.
- •Gluten free diet for previous 3 months and refusal to ingest gluten.
研究组 & 干预措施
Crofelemer and Diagnostic tests for cause of chronic diarrhea
125 mg tablets taken by mouth twice daily for 28 days
干预措施: Crofelemer (Drug)
Crofelemer and Diagnostic tests for cause of chronic diarrhea
125 mg tablets taken by mouth twice daily for 28 days
干预措施: Diagnostic tests for cause of chronic diarrhea (Diagnostic Test)
结局指标
主要结局
Number of Participants With a 50 Percent Decrease in Mean Stool Count
时间窗: Week 1
Number of Participants With a 50 Percent Decrease in Mean Stool Count
时间窗: Week 2
Number of Participants With a 50 Percent Decrease in Mean Stool Count
时间窗: Week 3
Number of Participants With a 50 Percent Decrease in Mean Stool Count
时间窗: Week 4
次要结局
- Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale(week 4)
- Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire(Baseline,week 4 of treatment)
- Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea(Baseline)
研究者
Brooks Cash
Visiting professor
The University of Texas Health Science Center, Houston