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临床试验/ACTRN12610000630011
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.

Southern Cross University0 个研究点目标入组 45 人开始时间: 2010年8月2日最近更新:
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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