NCT06351696Unknown不适用
The Effects of Low FODMAP Diets Accompanied With and Without Bromelain Supplement on Quality of Life, Disease Activity Index and Inflammation in Patients With Ulcerative Colitis With and Without Primary Sclerosis Cholangitis
National Nutrition and Food Technology Institute2 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2024年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- SCCAIQ
研究概览
简要总结
In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.
IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active mild to moderate UC
- •no other chronic disorders
排除标准
- •changed the type and dosage of their medication in the last month
- •those who have relapses that required hospitalization and change the type and dosage of medications during the intervention
- •patients who do not want to continue the study protocol
结局指标
主要结局
SCCAIQ
时间窗: At the 1st day and 8th week
Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms)
次要结局
- Serum TNF-a(At the 1st day and 8th week)
- IBDQ(At the 1st day and 8th week)
- Serum hsCRP(At the 1st day and 8th week)
- Serum TAC(At the 1st day and 8th week)
研究者
Dr Azita Hekmatdoost
Principle Investigator
National Nutrition and Food Technology Institute
研究点 (2)
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