The Efficacy of Fengliao Changweikang Keli for Patients With Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multicenter, Randomized, Placebo-controlled N-of-1 Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- IBS-SSS score
研究概览
简要总结
Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative medicine such as Traditional Chinese Medicine. However, lack of high-quality evidences being the obstacle for its development.
This study aims to evaluate the efficacy of Fengliao Changweikang Keli (FLCWK) on symptoms and health-related quality of life in mild to moderate IBS-D patients.
After 2-week run-in period, each participant will be randomized to a sequence of six 4-week double-blind treatment periods of FLCWK 8 g three times daily or placebo, separated by 2-week washout periods.
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
- 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
- •Aged between 18 and 75 years.
- •Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points[14].
- •Ability to complete questionnaires and provide written informed consent.
- •Current use of IBS medications (probiotics, antibiotics, antispasmodic, antidiarrheal and neuromodulators) should be prescribed on a stable dose at least 30 days prior to enrollment, and have no plan to change the dose, diet or lifestyle.
- •Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.
排除标准
- •History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.
- •Scores of IBS-SSS > 300 points or IBS-SSS < 75 points.
- •History of severe heart, kidney or liver diseases.
- •Pregnant or breastfeeding.
- •Current alcohol or drug abuse.
研究组 & 干预措施
FLCWK
FLCWK one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months
干预措施: FLCWK (Drug)
FLCWK
FLCWK one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months
干预措施: Placebo (Drug)
Placebo
Placebo one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months
干预措施: FLCWK (Drug)
Placebo
Placebo one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months
干预措施: Placebo (Drug)
结局指标
主要结局
IBS-SSS score
时间窗: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).
The severity score questionnaire consists of 5 items and each item is rated on a scale of 0-100 points, leading to a total score of 0-500 points. An improvement of more than 50 points for IBS-SSS questionnaire is considered clinical effective.
次要结局
- IBS-QOL score(At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).)
- self-reported symptoms including abdominal pain and diarrhea(At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).)
研究者
DONG WU
Chief physician of Gastroenterology
Peking Union Medical College Hospital