A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Symptom Score Improvement of 3 or More During or After 6 Months
研究概览
简要总结
Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypothesise that an improvement or even normalisation of this balance may be achieved by the use of vaccines and dietary oats. The combined use of oral typhoid vaccine and cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats modifies the microbial environment inside the intestinal lumen. Or study aim is to show if such treatment brings symptom relief to patients with ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ulcerative colitis of at least 4 months duration
- •disease activity index score (Walmsley) >5 and </=13
- •patients taking no ulcerative colitis relevant medicine, or stable doses of aminosalicylates or maximum 10mg prednisolon daily the last 2 weeks before study entry. They must remain on the same dose throughout the study (6 months).
- •stool examination negative for enteric pathogens, clostridium difficile toxin and parasites
排除标准
- •ulcerative colitis disease activity index >13
- •symptoms of bowel obstruction
- •other serious medical condition
- •use of any of the study vaccines during the last two years
- •use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first vaccine dose, or planned use during study period
- •pregnant or planning to become pregnant
- •breastfeeding
- •chronic administration of prednisolone more than 10mg per day or steroids of equivalent dose the last 2 weeks before the first vaccine dose
- •treatment with anti-tumor necrosis factor within 3 months prior to the first vaccine dose
- •use of other immunosuppressants or immune modifying drugs within 30 days prior to the first vaccine dose
结局指标
主要结局
Symptom Score Improvement of 3 or More During or After 6 Months
时间窗: 6 months
No patient completed the study, therefore we have no information to report.
次要结局
- Symptom Score Improvement of 2 or More During or After 6 Months(6 months)
研究者
Gunnar Nysæter
Senior Consultant
Haukeland University Hospital