Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if a dietary supplement called ButyMixx can help people with ulcerative colitis in remission feel better and keep their intestines less inflamed.
ButyMixx contains:
- Sodium butyrate, a substance normally produced by our gut microbiota that helps protect the intestinal lining and reduce inflammation.
- A "beneficial" yeast (Kluyveromyces marxianus), similar to probiotics, which may support the balance of the intestinal microbiota.
It will also learn about the safety of dietary supplement. The main questions it aims to answer are:
-
Does ButyMixx after 2 months of supplementation
-
Symptoms improve,
-
Quality of life improves,
-
Intestinal inflammation decreases ,
-
The gut microbiota becomes more "balanced"
-
What medical problems do participants have when taking ButyMixx ?
Participants will:
-
Take 2 sachets of ButyMixx per day for 8 weeks
-
Before starting and at the end of the 8 weeks:
-
Provide a stool sample
-
Complete a quality-of-life questionnaire
-
Be assessed by a doctor using a symptom score
详细描述
ButyMixx Study A novel natural supportive strategy for Ulcerative Colitis in remission What is ulcerative colitis? Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by recurrent inflammation of the colonic mucosa, leading to symptoms such as diarrhea, rectal bleeding, abdominal pain, and fatigue.
Even during clinical remission, when symptoms are minimal or absent, the intestinal mucosa often remains fragile and susceptible to new inflammatory flares.
For this reason, current research is increasingly focused not only on treating acute disease activity, but also on identifying strategies able to maintain mucosal health over time, improve quality of life, and reduce the risk of relapse.
The role of the gut microbiota
The human gut hosts a complex community of microorganisms, known as the gut microbiota, which plays a crucial role in:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence.
- •Age between 18 and 75 years old
- •Ability of subject to participate fully in all aspects of this clinical trial.
排除标准
- •Patients that have active UC, determined by clinical, endoscopic and histopathological evidence
- •Known diagnosis of CD( Crohn disease), indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis
- •Positive stool culture for active C. difficile
- •Pregnant women
- •Patients under antibiotic and/or probiotic treatment within 10 days prior to Visit 1.
研究者
Savarino Edoardo Vincenzo
Professor
University of Padova