Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Gut microbiome analysis
研究概览
简要总结
Probiotics are one of the adjunctive treatments that have been extensively explored for Ulcerative colitis (UC) disease management. Probiotics, a group of beneficial bacteria, can bring various health benefits when adequately supplied to the body, especially for gut wellness. In particular, for UC patients, gut dysbiosis is one of the contributing factors in their pathogenesis. Thus, the supplementation of probiotics in combination with standard treatment can potentially help in relieving symptoms as well as promoting mucosal healing for long-term remission.
详细描述
Inflammatory bowel disease (IBD) has progressively risen globally, becoming more prevalent in recent years. Crohn's disease (CD) and UC are classified as two of IBD variations resulting in range of symptoms that can negatively impact patients' quality of life. The underlying cause of UC is complicated, encompassing genetic, environmental, and immunological factors. Despite breakthroughs in medical treatment, obtaining and maintaining remission in UC remains a substantial challenge, especially for people with mild to moderate disease severity. Standard treatment for UC consists of anti-inflammatory drugs, antibiotics, immunosuppressants, and, in severe instances, biologic therapy and possibly surgery. While these procedures have proven effective, a significant proportion of patients endure ongoing symptoms or undesirable consequences, emphasizing the need for alternative or supplementary therapeutic options.
In recent years, studies have focused on the gut microbiota as an important contributor in the pathophysiology of UC. Individuals with UC frequently exhibit altered microbial composition and dysbiosis, implying a possible role for gut microbiome-modulating therapies. Probiotics, which are live microorganisms that provide health advantages have emerged as a viable area for research in UC management. The rationale for using probiotics in UC lies in their potential to restore microbial balance, strengthen the intestinal barrier, and modulate the immune response. Previous studies have shown varying degrees of success with probiotics administration in terms of clinical and laboratory outcomes.
This proposed research seeks to contribute to the growing body of knowledge on the role of probiotics in UC by evaluating the efficacy of a multi-strain probiotic supplement. By combining these probiotics with standard care, we aim to explore the synergistic effects that may lead to improved clinical outcomes, endoscopic remission, and enhanced quality of life in individuals with mild to moderate UC. Understanding the impact of multi-strain probiotics on UC could provide clinicians with a valuable adjunctive tool for UC treatment strategies. Furthermore, elucidating the underlying mechanisms by which probiotics exert their effects enable better knowledge regarding the interplay between the gut microbiota and UC management. Thus, it can bring benefits to both patients and health institutions which helped in reducing the cost and maintaining long term remission.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC established by previous colonoscopy, with consistent histology, and clinical course.
- •UC involving at least the rectosigmoid, actively confirmed by colonoscopy at the beginning of the study.
- •Mild to moderate disease activity, defined as a PMS ranging from 3-
- •Use of medication at least 4 weeks prior to study.
排除标准
- •Crohn's disease or pouchitis.
- •Severe disease activity as defined in PMS, more than
- •Use of antibiotics within the last 2 weeks before study entry.
- •Change in dose of medication within the last 4 weeks before study entry and throughout the 12-week study period.
- •Use of probiotics preparation either prescribed or over the counter within 2 weeks before the study entry.
- •Use of NSAIDs for 1 week before and throughout the 12-week study period.
结局指标
主要结局
Gut microbiome analysis
时间窗: 12 weeks
The composition, diversity, and core microbiome of the gut bacterial community were identified via 16S rRNA sequencing and compared before and after taking multi-strain probiotics or placebo.
Faecal Calprotectin Level
时间窗: 12 weeks
Level of faecal calprotectin (mg/kg) measured before and after treatment with multi-strain probiotics or placebo, indicating levels of intestinal inflammation.
C-reactive Protein (CRP) Level
时间窗: 12 weeks
Level of CRP (mg/dl) measured before and after treatment with multi-strain probiotics or placebo, reflecting changes in systemic inflammation.
Erythrocyte Sedimentation Rate (ESR) Level
时间窗: 12 weeks
Rate of erythrocyte sedimentation (mm/hr) measured before and after treatment with multi-strain probiotics or placebo, as a marker of inflammation.
Change in White Blood Cell (WBC) Count
时间窗: 12 weeks
Number of participants with changes in WBC count (x10\^9/L) measured before and after treatment with multi-strain probiotics or placebo, to assess immune response and inflammation levels.
Change in Serum Metabolite Profile
时间窗: 12 weeks
Identification and quantification of serum metabolites via Liquid Chromatography-Mass Spectrometry (LC-MS) before and after treatment with multi-strain probiotics or placebo. The changes in metabolite concentrations will be compared to assess the metabolic response to the intervention.
Change in Proinflammatory Cytokine Gene Expression
时间窗: 12 weeks
Quantification of IL5, IL6, IL13, IL33, and TNFα gene expression using quantitative PCR (qPCR) before and after treatment with multi-strain probiotics or placebo. The changes in gene expression levels will be compared to evaluate the impact on proinflammatory cytokines.
次要结局
- Partial Mayo score (PMS)(12 weeks)
- International Physical Activity Questionnaire (IPAQ)(12 weeks)
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(12 weeks)
- Diet History Questionnaire(12 weeks)
- Three Days Food Record(12 weeks)
