DRKS00025802招募中未知
Gut Health Study - effectiveness of probiotics (OMNI-BiOTiC 10) combined with individual nutritional counselling with focus on prebiotic nutrition compared to solely individual nutritional counselling to improve gastrointestinal symptoms of bowel cancer survivors - a prospective double-blind randomized placebo-controlled trial - GutHealth
niversitäres Cancer Center Hamburg (UCCH) - Hubertus Wald Tumorzentrum0 个研究点目标入组 40 人开始时间: 2022年3月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •patients after bowel cancer disease with gastrointestinal symptoms
- •- 3 months to 5 years after cessation of cancer treatment
- •- expectancy > 6 months
- •- full-aged
- •- written informed consent
排除标准
- •- active infections > level 2 NCI-CTCAE V5.0
- •- severe systemic disease such as uncontrolled hypertension, heart failure or uncorntolled hyperglycaemia
- •- course of antibiotics in the past 8 weeks
- •- uncontrolled diabetes type 1 or 2
- •- immunosuppressive therapy, slow-healing wounds, ulcers, bone fractures
- •- pregnant women or those wishing to become pregnant as well as patients who do not apply contraceptive methods
- •- all conditions that could possibly compromise study outcome or patients safety
- •- all familial, psychologial or socialogical conditions that do not comply with the protocol
- •- participation in a study with an investigational product in the last 15 days before inclusion
- •- incarcerated patients
- •- enteral supplementation or parenteral nutrition or sip feeds (when covering over 50% of energy demand) after therapy of tumor cachexia
- •- presence of intestinal stenosis
研究者
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