Assessment of Medical and Nutritional Status Post-Probiotic Intake in Patients Diagnosed With Inflammatory Bowel Disease: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease course
研究概览
简要总结
The study is a single-center, randomized, single-blinded, controlled trial conducted at ZHUMC's endoscopy unit. It aims to assess the short-term effects of probiotic administration on disease course, quality of life, and nutritional status among patients diagnosed with inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn's disease (CD).
Patients with UC and CD will be recruited from the endoscopy unit's outpatients and divided into two groups: a control group and an intervention probiotic group. The intervention probiotic group will receive the probiotic intervention for 2 months. During the study period, two visits will be scheduled for all patients.
At each visit, medical and nutrition surveys will be filled out, and body composition measurements will be conducted. These assessments will help evaluate the impact of probiotic administration on the participants' disease progression, their quality of life, and their nutritional status.
Overall, the study aims to provide insights into the potential benefits of probiotic supplementation in managing IBD and improving the well-being of patients with these conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lebanese outpatients with histological diagnosis of Crohn's disease or Ulcerative Colitis from at least 6 months prior to the trial.
- •have stable inactive disease.
- •have not used any probiotics within the two months before the investigation.
排除标准
- •pregnant or lactating women
- •patients who use probiotics within the study period.
研究组 & 干预措施
Probiotic
Contains 4 strains of naturally-occurring bacteria including: Lactobacillus acidophilus, LA-5®, Bifidobacterium animalis, BB-12®, Streptococcus thermophiles, STY-31 and Lactobacillus delbrueckii subsp. Bulgaricus LBY-27 in concentration of 4.5 milliards CFU/capsule.
干预措施: Trilac (Dietary Supplement)
Control
The patients will be asked to continue their usual lifestyle without change in their usual medication and nutritional intake.
结局指标
主要结局
Disease course
时间窗: 8 weeks
Change in frequency of flares over 2 months
Nutrition Status
时间窗: 8 weeks
Change in macro- and micronutrient intake by administrating 24 h recall to be analysed by Nutritionist Pro Software
次要结局
- Quality of Life Status(8 weeks)
研究者
Zahra SADEK
Associate Professor
Lebanese University