The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
研究概览
简要总结
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.
详细描述
This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.
This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Inclusion Criteria
- •Men and women age 18-75 years
- •Rome III criteria for IBS
- •Symptom onset after apparent acute gastroenteritis
- •Symptoms of 6 months or greater duration
- •Normal gross appearance of the colonic mucosa other than erythema
- •Negative markers for celiac disease and inflammatory bowel disease
- •Normal thyroid function and serum calcium
- •Stable medication regimens for other medical conditions.
排除标准
- •Age <18 or >75 years
- •Previous diagnosis of or history compatible with IBS
- •Constipation-predominant IBS.
- •Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
- •History of/or presence of malignancy
- •Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. .
- •Current evidence of drug or alcohol abuse as judged by the investigator
- •Allergy to mesalamine or aspirin
- •Investigator perception of patient's inability to comply with the study protocol
- •Unstable psychiatric disease
- •Recent change in gastrointestinal medications
研究组 & 干预措施
Placebo
This arm will include those who are randomized to the placebo
干预措施: Placebo (Drug)
Mesalamine
This arm is for subjects randomized to the study drug, Mesalamine
干预措施: Mesalamine (Drug)
结局指标
主要结局
Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
时间窗: Baseline and 8 weeks
BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
次要结局
- Change in Average Bowel Frequency After 8-Week Treatment Period(Baseline and 8 weeks)
- Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.(Baseline and 8 weeks)
- Change in Average Bowel Consistency Score After an 8 Week Treatment Period.(Baseline and 8 weeks)
- Change in Average Abdominal Pain Score After an 8 Week Treatment Period(Baseline and 8 weeks)
- Change in Average Bloating Score After an 8 Week Treatment Period.(Baseline and 8 weeks)
研究者
Ashok K. Tuteja
Associate professor of medicine
University of Utah