Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Intestinal permeability changes
研究概览
简要总结
This exploratory study has been designed to determine the effect of the probiotic Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers of patients having positive serological evidences of Celiac Disease.
详细描述
Objective
This exploratory study has been designed to determine the effect of the probiotic Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers of patients having serological evidences of CD (positive serological markers). The testing period will be approximately three weeks between the results of serological testing and before the intestinal biopsy procedure during which time subjects are consuming a gluten-containing diet.
Study Design: A 3-weeks duration, placebo-controlled, double-blind, randomized study plan in ambulatory (non-hospitalized outpatients) patients, with 2 parallel groups. Treatment arms will be as follows:
A). Placebo 2 capsules 3 times daily (morning, evening and night).
B). Probiotics (Bifidobacterium infantis) 2 capsules 3 times per day (morning, evening and night).
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
- •Signing the Informed consent.
- •Men or women, 18-75 years old.
- •BMI between 18.5 and
- •Patients shall have a positive CD-related serology (combined positivity of DGP/tTG Screen plus IgA anti-tTG and or IgA a-DGP tests).
- •Patients will abstain from taking medications prohibited by the study from the 7 days prior the enrolment to the end of the trial: NSAIDs, aspirin, lactulose, probiotics and prebiotics in any form of administration (eg. Yogurts or other dairy products)..
- •Alcohol consumption is prohibited during the same period.
- •Patients should commit to attend on scheduled days, in accordance with the study calendar.
- •To be interested in participating the trial
排除标准
- •Patients with refractory CD or severe complications thereof, enteropathy-associated T-cell Lymphoma (EATL), ulcerative jejunitis, perforation, severe osteoporosis, malnutrition, among others.
- •Individuals with symptoms suggestive of lymphoma or any other serious CD complication taking special care in recently-diagnosed patients, 50 years old or older, in whom EATL must be ruled out by standard methods.
- •Individuals with other active chronic GI pathologies like Crohn's disease, ulcerative colitis and irritable bowel syndrome, microscopic colitis, and lactose intolerance.
- •Patients with Type 1 or Type 2 diabetes or other autoimmune diseases, such as autoimmune hepatitis and primary biliary cirrhosis.
- •Individuals with co-morbidities whose participation, in the investigator's judgment, would be inadvisable; for instance, unstable clinical conditions such as chronic obstructive pulmonary disease, angina pectoris, severe cardio-respiratory conditions, etc.
- •Individuals with symptomatic neurological or psychiatric conditions that could potentially interfere with the study.
- •Individuals with a clinical severity requiring immediate treatment at the consideration of the investigator.
- •Patients with hemoglobin levels less than 8.5 g/dL or who had donated blood in the last 56 days or donated a unit of plasma in the last 7 days.
- •Patients with a history of alcohol or drug abuse in the prior 2 years.
- •Individuals taking "prohibited" medications in relation to the study (see point 6, previous section).
- •Individuals with a history of neoplasia.
- •Individuals participating in another clinical study that either involves medications or concluded during the last 30 days.
- •Individuals previously exposed to Bifidobacteria species.
- •Subjects not willing to maintain a gluten-containing diet during the 3-weeks period of the trial
- •Pregnant women.
- •Allergies to goat milk; no recent or planned dietary changes, esp. regarding gluten intake.
结局指标
主要结局
Intestinal permeability changes
时间窗: 21 days
Subjects will come to the laboratory after an overnight fast, ingest the sugar probes, and collect all urine passed over the ensuing 24 hours into a pre-weighed container with 5 ml of 10% thymol in isopropanol. Urine will be vigorously mixed, total volume recorded, and aliquots rapidly frozen for subsequent transport and analysis. To evaluate intestinal permeability, subjects will ingest a solution containing: 5 g lactulose (Technilab, Montreal, Quebec, Canada), and 2 g mannitol (Sigma, St Louis, Missouri, USA) in 450 ml of water (osmolality approximately 1800 mOsmol/l).
次要结局
- Changes in the cytokine profile.(21 days)
研究者
Bai, Julio M.D.
Principle Investigator
Dr. C. Bonorino Udaondo Gastroenterology Hospital