Probiotics for the Treatment of Irritable Bowel Syndrome in Celiac Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Treatment of abdominal pain in celiac patients
研究概览
简要总结
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Clinical studies show that patients meeting the criteria for diagnosis for IBS have greater probability for being affected by celiac desease if compared to controls without IBS. Since one of the causes attributed to the onset of IBS is the modified flora gut, it is interesting to determine the beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease patients. The goal of the present study is to determine whether oral administration of a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would improve symptoms of adult celiac patients with IBS.
详细描述
This is a randomized, double blind study, placebo-controlled, carried out in three departments of gastroenterology in Southern Italy (Bari, Taranto e Castellana Grotte).
Celiac patients with Irritable Bowel Syndrome will considered eligible for inclusion. They will be between 18 and 65 years old and they will be in GFD for at least 2 year.
Will be excluded from the study patients with previous abdominal surgery, chronic disease, alarm signs of organic conditions, treatment with probiotics, prebiotics, antibiotics and antispasmodics in the previous month, immunodeficiency, pregnancy.
The size of the sample, which must show a benefit greater than 25% compared to placebo (untreated group that usually able to respond positive in 20% of cases), will require 58 patients per arm to ensure a power of 90% with an alpha error of 0.5.
Patient will be assigned consecutive numbers, starting with the lowest number available, and randomly assigned, with the use of a computer generated randomisation list using permuted block design, to receive orally either a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis or placebo (sachets identical in taste and appearance to the active study product except for the absence of probiotic mixture) once a day.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Celiac patients aged between 18 and 65 years
- •Diagnosis of IBS on the basis of Rome III criteria
- •Informed consent
排除标准
- •Previous sigmoidoscopy or colonoscopy in the past 5 years
- •Known concomitant organic diseases, including inflammatory bowel disease and other systemic diseases significant
- •Treatment with antispasmodic drugs within the previous month
- •Are pregnant
- •Immunodeficiency
- •Previous abdominal surgery, with the exception of the hernia repair or appendectomy
- •Treatment with antibiotics within the previous month
- •Treatment with probiotics and / or prebiotics within the previous month
- •Participation in other clinical trials
结局指标
主要结局
Treatment of abdominal pain in celiac patients
时间窗: 14 weeks
Primary outcome will be the incidence in IBS in celiac patients receiving probiotics mixture as compared to those receiving placebo. IBS will be diagnosed and categorised according to ROME III criteria.
次要结局
未报告次要终点
研究者
Ruggiero Francavilla
Consultant in Gastroenterology
University of Bari