Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change in the Irritable Bowel Symptom Severity Scale
研究概览
简要总结
New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.
详细描述
In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS)
- •increased intestinal permeability on Lactulose/Mannitol permeability test
- •able and willing to cooperate with the study
- •*absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration
排除标准
- •current participation in another research protocol or unable to give informed consent
- •women with a positive urine pregnancy test or breastfeeding
- •history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue
- •+ hydrogen breath test for bacterial overgrowth
- •+ antiendomysial antibody titer
- •use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study
- •known allergy to glutamine
- •abdominal surgery except for removal of gallbladder, uterus, or appendix
- •Abnormal blood urea nitrogen(BUN) and/or creatinine
研究组 & 干预措施
Glutamine supplementation
Glutamine
干预措施: Glutamine (Drug)
Placebo
Whey protein powder
干预措施: Glutamine (Drug)
结局指标
主要结局
Change in the Irritable Bowel Symptom Severity Scale
时间窗: baseline and 8 weeks following therapy
The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.
次要结局
- Intestinal Permeability(baseline and 8 weeks following therapy)
- Stool Frequency(Baseline and 8 weeks following therapy)
- Stool Consistency(Baseline and 8 weeks following therapy)
研究者
Nicholas Verne
Principal Investigator
Tulane University