Double-blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients With Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score
研究概览
简要总结
Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are considered to be poor responders to the diet. Bacterial overgrowth in the small intestine accounts for some of the refractory patients.
This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of patients who are poorly responsive to a gluten-free diet and whether this impacts their breath test results.
详细描述
A symptom questionnaire will be administered at study initiation, 2 weeks and 12 weeks. Patients will undergo a breath test which involves drinking a sugar (lactulose) solution and breathing into a machine. This technique will identify the presence of bacteria in the small intestine. They will be randomly selected to receive either an antibiotic (rifaximin) or placebo three times a day for 10 days to treat their bacterial overgrowth.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients age 18 or older
- •Biopsy proven celiac disease
- •Persistent symptoms of diarrhea, gas, bloating and/or cramping despite a gluten free diet for at least 1 month
- •Women that are not pregnant or lactating can be included. All women must have a documented negative pregnancy test at the initiation of the study. Women who become pregnant during the study will be asked to discontinue the study drug and will be followed up until the outcome of pregnancy is known. Women of child bearing potential must be practicing an effective method of birth control (eg: prescription oral contraceptive, contraceptive injections, intra-uterine device (IUD), double barrier method, contraceptive patch, male sterilization) before entry and throughout the treatment period.
排除标准
- •antibiotic use for any indication within preceding one month
- •use of bismuth compounds within preceding month
- •concomitant use of pancreatic supplements
- •concomitant use of antispasmodics
- •concomitant use of immunomodulators such as corticosteroids, budesonide, alkylating agents and antimetabolites.
- •concomitant use of probiotics
- •concomitant use of prokinetic agents
- •concomitant use of 5-hydroxytryptamine receptor (5HT3) antagonists,5-hydroxytryptamine receptor (5HT4) antagonists.
- •concomitant use of antimotility agents (e.g loperamide)
- •concomitant use of antidiarrheal agents
- •diagnosed microscopic colitis or inflammatory bowel disease
- •other causes of malabsorption: pancreatic insufficiency, giardiasis and enteropathy associated with T cell lymphoma.
- •other diseases: renal or hepatic insufficiency.
- •pregnant patients and lactating females. In addition women of child bearing age will be excluded if they are not using one of the methods of contraception like oral contraceptives,intrauterine device.
- •and double barrier methods.
- •patients with tuberculosis or a positive purified protein derivative (PPD) test and infection with other mycobacterial diseases.
- •allergy and/or potential emergence of drug resistance to rifampicin and rifamycin compounds.
研究组 & 干预措施
Rifaximin 400mg
Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days.
干预措施: Rifaximin (Drug)
Placebo
Placebo pills given 3 times a day for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Baseline Gastrointestinal Symptom Rating Scale (GSRS) Score
时间窗: Baseline (week 0)
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Week 2 Gastrointestinal Symptom Rating Scale (GSRS) Score
时间窗: Week 2
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
Week 12 Gastrointestinal Symptom Rating Scale (GSRS) Score
时间窗: Week 12
Validated seven point questionnaire that assesses gastrointestinal symptoms for five symptom areas, including abdominal pain, reflux, indigestion, diarrhea, and constipation. Individual scores are calculated for each symptom area and the mean of the scores is used to derive an overall GSRS score. Scores range from 0-7, with higher scores indicating gastrointestinal discomfort.
次要结局
- Percentage of Participants With Abnormal Breath Test(Up to 12 weeks)