Sulfur on the Breath: Using Breath Biomarkers to Monitor Gut Microbial Sulfur Metabolism During Elemental and Reduced Sulfur Dietary Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
This study aims to test whether a short liquid-based diet, followed by a low-sulfur eating plan, is safe, manageable, and helpful for people with mild to moderate ulcerative colitis. Investigators want to see if this approach can improve gut health, lower inflammation, and reduce symptoms. Investigators will also test breath samples as an easy, non-invasive way to track gut bacteria activity and disease changes. Investigators believe this diet plan can reduce harmful gut bacteria that produce irritating sulfur compounds, leading to better gut health and measurable improvements that can be detected through breath testing.
详细描述
Purpose To determine whether a short-term elemental diet followed by a reduced sulfur diet is a safe, tolerable, and effective non-pharmacologic strategy to improve clinical outcomes, reduce inflammation, and beneficially modulate the gut microbiome in adults with mild-to-moderate ulcerative colitis. A secondary purpose is to validate breath-based biomarkers as non-invasive tools to monitor sulfur metabolism and disease activity. Breath biomarkers include volatile organic compounds (VOCs) and exhaled breath condensate (EBC) to assess sulfur-related metabolites.
Hypothesis A 2-week elemental diet followed by a 10-week reduced sulfur diet will reduce intestinal inflammation and improve clinical outcomes by shifting the gut microbiome away from pro-inflammatory, sulfur-metabolizing bacteria, resulting in reduced sulfur metabolite production detectable through exhaled volatile organic compounds and exhaled breath condensate.
Justification Despite advances in biologic therapies, many UC patients fail to achieve sustained remission, and current treatments do not address upstream drivers such as diet-microbiome interactions. Elemental diets have demonstrated efficacy in Crohn's disease but remain understudied in UC. Emerging evidence links dietary sulfur, microbial sulfur metabolism, and toxic metabolites to UC pathogenesis. This study addresses critical gaps by testing a feasible dietary intervention and validating non-invasive breath biomarkers for real-time disease monitoring and precision nutrition.
Objectives
- Evaluate the clinical efficacy, safety, and feasibility of an elemental diet followed by an reduced sulfur diet.
- Characterize changes in gut microbiome composition, inflammatory markers, and sulfur-related metabolic outputs.
- Validate breath-based volatile organic compounds and exhaled breath condensate as biomarkers of sulfur metabolism and treatment response.
- Identify microbial and metabolic signatures predictive of dietary response.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-70 years.
- •=Diagnosis of mild-to-moderate ulcerative colitis, defined by a partial Mayo score (pMayo) of 2-
- •Evidence of active inflammation at enrollment, defined as:
- •C-reactive protein (CRP) > 5 mg/L; or
- •Fecal calprotectin (FCP) > 200 µg/g.
- •Receiving stable medical therapy for ulcerative colitis for at least 8 weeks prior to enrollment.
- •No corticosteroid use at the time of recruitment.
- •Under consideration by the treating physician for treatment escalation or biologic switch due to inadequate response to current therapy.
排除标准
- •Partial Mayo score (pMayo) >
- •Pregnant or breastfeeding.
- •Body mass index (BMI) < 18 kg/m².
- •History of an eating disorder.
- •Severe psychiatric disorder.
- •Severe medical conditions, including:
- •Active cancer;
- •Significant cardiovascular disease;
- •Diabetes mellitus; or
- •Severe food allergies.
- •Known allergy or intolerance to corn, dextrose, or maltodextrin.
- •Antibiotic use within 3 months prior to enrollment.
- •Probiotic use within 3 months prior to enrollment.
- •Use of herbal anti-inflammatory supplements during the study period, including but not limited to:
- •Serrapeptidase;
- •Curcumin;
- •Boswellia; or
- •Bromelain.
- •History of major gastrointestinal surgery, including:
- •Total colectomy; or
- •Short bowel syndrome.
- •Inability or unwillingness to comply with study procedures, including anticipated travel or other commitments that may interfere with participation.
研究者
Natasha Haskey
Principle Investigator, Research Associate, Department of Biology
University of British Columbia