NCT01779765Unknown4 期
The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome- a Double Blind, Placebo - Controlled, Randomized Study
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Improvement in IBS score.
研究概览
简要总结
This study objective is to assess the short and long term effects of partially hydrolyzed guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Fulfillment of the Rome III criteria for IBS.
- •Aged 20-68 years at the time of screening.
- •Provision of written informed consent.
- •Commitment of availability throughout the 6 months study period.
排除标准
- •Major abdominal surgery in the past.
- •The presence of any active (organic)GI disease.
- •Past or present major medical or psychiatric illness.
- •Any concomitant disease.
- •Alarming symptoms (rectal bleeding, weight loss, etc.)
- •Pregnancy.
- •Family history of colorectal carcinoma or inflammatory bowel disease (IBD).
- •Abnormal laboratory studies (blood biochemistry , liver enzymes,complete blood count), abnormal thyroid function.
- •Non-adjusted diet in the case of lactose or gluten intolerance.
- •Recent travel to regions with endemic parasitic diseases.
结局指标
主要结局
Improvement in IBS score.
时间窗: 2 years
IBS scoring - Francis severity IBS score.
次要结局
- Quality questionnaire(2 years)
研究者
研究点 (2)
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