Exploring the Use of a Reduced Sulfur Diet to Improve Disease Severity in Ulcerative Colitis: An 8-week Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mayo Score: Change is being assessed
研究概览
简要总结
A)Background:
Approximately 44% of patients with Inflammatory bowel disease have Ulcerative colitis(UC) which is a lifelong, chronic disease, starting in early adulthood, where the colon becomes inflamed and ulcerated due to a complex interaction between genetics, altered immune function, and environmental factors2such as dietary intake. While the etiology of UC is not clear, it is hypothesized the abnormal immune response and chronic inflammation may be caused by dysbiosis of the intestinal microbiota and decreased epithelial barrier function. Substantial evidence suggests that higher than normal levels of hydrogen sulfide (H2S) in the colon plays a role in the etiology of UC. The higher levels of H2S and sulfate-reducing bacteria (SRB) found in the feces of patients with UC is likely caused by the reduced conversion of H2S to thiosulfate by rhodanese (thiosulfate transferase enzyme)12, and increased colonization or activity of SRB. For example, SRB has been identified as the predominant bacterial group in patients with UC compared to the minority group in healthy individuals, and SRB growth is stimulated by the presence of sulfur-rich amino acids. Dietary intervention may help to repair the dysbiosis existing in the microbiome of the patient with UC, but research about food and recurrence of UC is conflicting. Dietary components such as sulfur and sulfates also appear to play a role in the recurrence of UC; although a recent review of the relationship between sulfur-containing foods and UC calls for more randomized controlled trials (RCTs) examining a reduced sulfur diet in UC. With the body of evidence described above, there is a compelling reason to consider that sulfur and sulfate-containing foods contribute to developing severe UC. Thus, understanding how dietary modulation of sulfur intake within the context of UC impacts disease status is the focus of this proposal.
详细描述
A)Overview and Specific Aims:
Higher than normal levels of hydrogen sulfide (H2S) in the colon plays an important role in the etiology of ulcerative colitis (UC). Increased H2S impairs the colonic cell's ability to oxidize butyrate and other short-chain fatty acids required for cell nutrition. Sulfur in the human body is largely provided by diet; high intakes of sulfur and sulfate-containing foods have been found to be associated with an increased risk of recurrence of UC. Hence, it is only rational to identify whether foods high in sulfur or sulfate increase the risk of poor outcomes in UC. To our knowledge, there have been no studies investigating the impact of a reduced sulfur diet compared to conventional management on disease severity in patients with UC. Our main objectives are to identify if a reduced sulfur diet added to conventional management results in 1. improved disease severity, 2. reduced exposure of the host to sulfur-containing compounds, and 3. alterations in the microbiome of the patients. To achieve these objectives, we will randomly allocate the patients to either the conventional management (CM) or reduced sulfur diet intervention group (INT) and obtain the Mayo score, concentrations of fecal hydrogen sulphide (H2S), methanethiol (MT), and dimethyl sulphide (DMS), and urinary dimethyl sulfone (DM202) and 3-indoxyl sulfate and fecal microbiome at baseline and after 8 weeks. The INT group will also receive diet counselling by a registered dietician (RD).
B)Hypothesis:
A reduced sulfur diet would result in improved disease severity compared to conventional management in UC patients.
C)Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Experiencing a severe UC flare.
- •Have any other major medical comorbidities (diabetes, active malignancy within the past 5 years, active infections, severe respiratory or cardiac disease, or acute or chronic kidney disease).
- •Have a history of previous bowel surgery.
结局指标
主要结局
Mayo Score: Change is being assessed
时间窗: Baseline and week -8
Mayo score is used for patients with active disease.Mayo Score is one of the most commonly used indices of UC severity. Score ranges from 0-12 with a score ≤ 2.5 indicating remission. Mayo Score includes ratings of stool frequency, rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. Higher score means worse outcomes. For the patients in remission disease activity will be measured using the non-invasive partial Mayo Score calculated at baseline and week 8. Partial Mayo score excludes mucosal appearance at endoscopy but includes stool frequency, rectal bleeding, and physician rating of disease .
次要结局
- Physical Activity Monitoring: Change is being assessed(Baseline, Week-8)
- Patient Survey Change is being assessed.(Baseline, Week-8)
- Urinary sulfate: Change is being assessed(Baseline, Week -8)
- Health related quality of life: Change is being assessed(Baseline, Week-8)
- Dietary intake: Change is being assessed(Baseline, Week-8)
- Serum metabolomics: Change is being assessed(Baseline, Week-8)
- Fecal sulfate: Change is being assessed(Baseline, week-8)
- Stool microbiome: Change is being assessed(Baseline, Week-8)
- Cytokines Measurements: Change is being assessed(Baseline, Week-8)
研究者
Maitreyi Raman
Clinical Associate Professor, Director Clinician Investigator Program (CIP), Medical Director Alberta's Collaboration of Excellence for Nutrition in Digestive Diseases (Ascend) , Medical Director Nutrition Services
University of Calgary