Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
研究概览
详细说明
Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).
Fecal & urine samples will be collected before/after each phase. Blood will also be collected.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Abigail Raffner, RD PhD
- 电话号码：216-327-6003
- 邮箱：Abigail.Raffner@uhhospitals.org
研究联系人备份
- 姓名：Sargun Singh, M.B.B.S.
- 电话号码：216-333-6085
- 邮箱：sargun.singh@uhhospitals.org
学习地点
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Ohio
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Chagrin Falls、Ohio、美国、44122
- 招聘中
- UH Minoff Health Center
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副研究员：
- Jeffry Katz, MD
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接触：
- Abigail Basson, RD PhD
- 邮箱：Abigail.Basson@uhhospitals.org
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Cleveland、Ohio、美国、44106
- 招聘中
- University Hospitals Cleveland Medical Center
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副研究员：
- Jeffry Katz, MD
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接触：
- Abigail Basson, RD PhD
- 邮箱：Abigail.Basson@uhhospitals.org
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副研究员：
- Vu Nguyen, MD
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Westlake、Ohio、美国、44145
- 招聘中
- UH Westlake Health Center
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接触：
- Abigail Basson, RD PhD
- 邮箱：Abigail.Basson@uhhospitals.org
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副研究员：
- Vu Nguyen, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Age range from: 18 to 70 years. Male or female. Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (<6 score).
Capable of providing consent to participate. Able to complete daily surveys and take oral nutrition. Able to record meal intake. Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).
Exclusion Criteria:
Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
Known drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture/narrowing. Presence of an ostomy. Known active malignancy. Antibiotic use within last 14 days. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of <1 natural bowel movements per 3 consecutive days. Unable to access to technology that permits the daily completion of study related activities.
Change in IBD medication within past 4 weeks. Body mass Index <18 kg/m or ≥35 kg/m. Documented C.difficile colitis within four weeks of screening. Bariatric surgery Phenylketonuria
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Crohn's participants
Crohn's participants will consume artificial sweetener: sucralose
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Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
|
|
实验性的：Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose
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Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in fecal microbiome measured by metagenome analysis
大体时间：Baseline, three weeks pre-intervention, and three weeks after intervention
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Quantify the change in the fecal microbiome using metagenome analysis
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Baseline, three weeks pre-intervention, and three weeks after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Fecal Myeloperoxidase activity (MPO)
大体时间：Baseline, three weeks pre-intervention, three weeks post-intervention
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Quantify the change in fecal MPO
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Baseline, three weeks pre-intervention, three weeks post-intervention
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Change in Fecal Calprotectin
大体时间：Baseline, three weeks pre-intervention, three weeks post-intervention
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Quantify the change in fecal calprotectin
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Baseline, three weeks pre-intervention, three weeks post-intervention
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Change in Crohn's Disease Activity Index (CDAI)
大体时间：Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
Quantify the change in Crohn's Disease Activity Index.
The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity.
It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation.
Each component is multiplied by a specific weighting factor and summed to calculate a total score.
Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity.
A score of <150 indicates clinical remission, while a score of >450 indicates severe disease.
A negative change from baseline indicates clinical improvement.
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Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
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Change in C-reactive protein (CRP)
大体时间：Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
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Quantify change in CRP
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Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
|
合作者和调查者
调查人员
- 首席研究员：Fabio Cominelli, MD PhD、University Hospitals Cleveland Medical Center
- 首席研究员：Abigail Raffner, RD PhD、Case Western Reserve University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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