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临床试验/NCT00510978
NCT00510978Unknown2 期

One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis

University College Cork2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2002年1月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
360
试验地点
2
主要终点
To determine whether ingestion of probiotic preparations (containing Lactobacillus salivarius subsp. salivarius UCC118 or Bifidobacterium infantis 35624) can help in the maintenance of remission of patients with Crohn's disease and ulcerative colitis

研究概览

简要总结

All of us have millions of bacteria living in our gut. These bacteria are very important to our health providing us with protection against infections of the gut, allowing us to gain extra nutritional value from food we eat and helping our immune system. Changes in the balance of these many bacteria can make us vulnerable to infections both from within and from outside the gut. Certain bacteria may also be directly associated with some diseases of the gut. Research by doctors and scientists into relationships between the bacteria normally found in our gut and certain diseases of the gut is helping to develop food supplements and other therapies to treat these diseases.

This study involves research into the usefulness and safety of two probiotic products in maintaining remission in Crohn's disease and ulcerative colitis. Approximately 360 patients with Crohn's disease and ulcerative colitis from Ireland, Finland and Spain will be involved in the study. The yoghurts used in this study contain either Lactobacillus salivarius subsp. salivarius or Bifidobacterium infantis.

详细描述

There is a growing body of evidence that the enteric bacterial flora contribute to the pathogenesis of inflammatory bowel disease (IBD; Crohn's disease and Ulcerative Colitis) (Targan S and Shanahan F Inflammatory Bowel Disease: From Bench to Bedside, Williams and Wilkins 1994).

It has recently been found that patients suffering active Crohn's disease have significantly less recoverable bifidobacteria in their faeces compared to healthy individuals. This reduction in bifidobacteria numbers was observed to be directly correlated with decreased levels of B-D-galactosidase production and activity (Favier C et al. Dig Dis Sci 1997;42:817-822). B-D-galactosidase is an enzyme produced by bifidobacteria. These results support suggestions proposed in other studies (Bartram HP et al. Am J Clin Nutr 1994;59:428-432) that strains of bifidobacteria may play important roles in maintaining a balanced healthy intestinal microflora.

In Crohn's disease, there is extensive clinical evidence indicating the importance of the continuity of the faecal stream in disease recurrence.

Ingestion of bifidobacteria can improve gastrointestinal transit. In elderly individuals, mild constipation can be at least partially corrected through the consumption of milk fermented by bifidobacteria (Seki M et al. Nutr Food 1978;4:379-387). In addition, colonic transit times of women were significantly accelerated in the sigmoid colon following consumption of a milk fermented by bifidobacteria sp. and yoghurt cultures (Grimaud JC et al. Gastroenterol Clin Biol 1993;17:A127), but not by traditional yoghurt cultures alone (Grimaud JC et al. Les bact_ries lactiques, 1994;406).

Several genetically engineered 'knock out' and transgenic animal models of IBD have been reported in which the role of the enteric flora has been directly demonstrated by comparing animals raised in germ free versus conventional facilities. For example, the gastrointestinal Crohn's-like inflammation that occurs in interleukin-10 (IL-10) deficient mice is attenuated when the animals are kept in a germ free environment and becomes more pronounced and widespread when they are switched to conventional facilities. (Kuhn R et al. Cell 1993;75:263-274).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Age - patients over 75 years will be excluded.
  • Be pregnant, or have the desire to become pregnant during the study period.
  • Patients with clinically significant immunodeficiency (quantitative immunoglobulin levels will be performed before entry to trial).
  • Patients who are considered to be poor clinical attendees or be unlikely for any reason to be able to comply with the trial.
  • Concomitant Drug usage - Patients may not be receiving any treatment with 6-Mercaptopurine, Azothioprine or cyclosporin.
  • Patients may not be receiving treatment involving experimental drugs.
  • Patients who have been on antibiotics within the previous month or who are likely to require antibiotics during the trial period will be excluded.
  • Previous surgery - patients will be excluded if the have undergone resection of more than one (1) metre of bowel in the past. Patients who have undergone less extensive surgical resection of bowel will be eligible provided there is objective (endoscopic or radiological) evidence of recurrence.
  • Malignancy or any concomitant end-stage organ disease.

研究组 & 干预措施

3

Placebo Comparator

Placebo

干预措施: Placebo (Biological)

2

Active Comparator

Lactobacillus salivarius UCC118

干预措施: Lactobacillus salivarius UCC118 (Biological)

1

Active Comparator

Bifidobacterium infantis 35624

干预措施: Bifidobacterium infantis 35624 (Biological)

结局指标

主要结局

To determine whether ingestion of probiotic preparations (containing Lactobacillus salivarius subsp. salivarius UCC118 or Bifidobacterium infantis 35624) can help in the maintenance of remission of patients with Crohn's disease and ulcerative colitis

时间窗: One year

次要结局

  • Evaluation of the immunological and biochemical parameters of the immuno-inflammatory response and an assessment of the faecal flora in patients consuming the probiotic and control products(One Year)

研究者

申办方类型
Other

研究点 (2)

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