ACTRN12610000630011已完成2 期
Intestinal microbiota in Coeliac disease (CD) compared to non-coeliac patients using Deoxyribonucleic Acid (DNA) methods of analysis, followed by a double-blind placebo controlled study assessing the microbiological and quality of life improvements after supplementation with a specific probiotic supplement.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years(—)
- 性别
- All
入选标准
- •1.Participants who have had Coeliac disease confirmed by small bowel biopsy
- •2.Participants who have followed a gluten free diet for at least 12 months
- •3.At least 12 months since small bowel biopsy diagnosis
排除标准
- •1.Pregnant women
- •2.Participants under the age of 18
- •3.Individuals with cancer or who are HIV positive
- •4.Patients who have been diagnosed with Coeliac disease in the past 12 months
- •5.Patients who consume a gluten containing diet
- •6.Individuals with gastrointestinal pathology such as cancer, Crohn’s disease or ulcerative colitis
- •7.Individuals with short bowel syndrome
- •8.Individuals who have had recent oral or bowel surgery
- •9.Individuals currently being treated with chemotherapy or radiotherapy
- •10.People who are using or have used non-steroidal or steroidal anti-inflammatory drugs, antibiotics, antipyretics or the oral contraceptive pill in the four weeks prior to the start of the trial
- •11.Individuals with serum urea, electrolytes and creatinine greater than 2 times the upper limit of normal at baseline
- •12.Individuals with liver function tests greater than 3 times the upper limit of normal at baseline
- •13.Participants unwilling to comply with the study protocol
- •14.Any other condition which, in the opinion of the investigators, could compromise the study
- •15.Individuals with active alcohol and or illicit drug dependence.
研究者
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