NCT07520461招募中不适用
Microbiome-targeted Diet Therapy in Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fecal H2S Production
研究概览
简要总结
The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Ability and willingness to provide informed consent
- •Age at least 18 years old
- •Diagnosis of UC based on clinical and endoscopic criteria
- •UC duration of at least 3 months
- •Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization
- •On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below).
- •≥4 weeks if no medication, 5-ASA
- •≥8 wk for immunomodulatory therapy
- •≥12 wk for biologics
- •Ability to comply with study requirements in the opinion of the primary investigator
排除标准
- •Moderate or severe UC as defined by UCEIS ≥5
- •History of stomach surgery or bowel resection
- •Antibiotic use within 3 months
- •Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)
- •Pregnancy or breastfeeding
- •History of anaphylactic food allergies
- •Intolerance of high dietary fiber content
- •Ongoing alcohol or drug abuse
- •Habitual vegan diet pattern
- •Insufficient freezer space to accommodate meal delivery
研究组 & 干预措施
On-Off Cycling Intervention
Experimental
1 week standard diet, followed by
1 week high-protein, high-fiber diet, followed by
1 week standard diet, followed by
1 week high-protein, high-fiber diet
干预措施: High Protein, High Fiber (HPHF) Diet (Other)
结局指标
主要结局
Fecal H2S Production
时间窗: Week 4
Assessed from stool samples
次要结局
未报告次要终点
研究者
研究点 (1)
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