A Pilot Study Examining Low Sulfur Diet as Treatment for Persistent Symptoms in Quiescent Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dietary Protein Intake as assessed by 24 hour diet recall
研究概览
简要总结
The goal of this study is to learn about a low sulfur diet in patients with Crohn's disease. Study participants will be randomized to receive a low sulfur diet or usual diet for 8 weeks. Participants will work with study nutritionists and receive dietary educational materials. Participants will attend 2 in-person visits as well as 6 phone visits during the study. In addition, subjects will undergo testing, including a test to measure rectal sensation, a test to look for small intestinal bacterial overgrowth, and a test to measure leaky gut.
详细描述
Even in the absence of active inflammation, persistent symptoms are reported in up to 46% of inflammatory bowel disease (IBD) patients, especially in Crohn's disease (CD). While persistent symptoms in quiescent Crohn's disease result in worsened quality of life and worse outcomes, evidence-based treatments do not currently exist due to lack of mechanistic understanding of this condition. The gut microbiome, which are the microbes that live in our gut, have been suggested as a potential cause of persistent symptoms. Diet is a major influence on the microbiome and may have a modifiable impact on persistent symptoms in Crohn's disease. However, this has not been well established.
The investigators propose a study period of approximately 8 weeks to evaluate the effects of a low sulfur diet in Crohn's disease. Participants will have an initial phone visit to determine eligibility to participate in the study and to review potential participants normal diet with a study nutritionist.
The treatment phase of 8 weeks will begin at the baseline visit (week 0). Participants will be randomized to receive a low sulfur diet or usual diet for 8 weeks. Participants on the low sulfur diet will meet with the study nutritionist to receive educational materials and recipes for the low sulfur diet. During this visit, participants will undergo testing, including a rectal barostat test to evaluate rectal sensation, glucose hydrogen breath test to assess for small intestinal bacterial overgrowth, lactulose-mannitol test to evaluate intestinal permeability, and a 24-hour urine sample to measure urine sulfate levels. Participants will be asked to collect saliva, serum, and stool samples.
Participants will then have phone visits every 2 weeks (week 2, week, 4, and week 6). Study nutritionists will monitor their dietary history and answer questions about the low sulfur diet if applicable.
At the conclusion of the 8 weeks, participants will have a final in-person study visit where rectal barostat, glucose hydrogen breath test, lactulose mannitol testing, and 24-hour urine sulfate level will be repeated. Stool and serum samples will be collected by participants.
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
- 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
- •Prior diagnosis of Crohn's disease based on endoscopic, radiographic, and/or histologic findings
- •Quiescent Crohn's disease as defined by fecal calprotectin level less than 150 micrograms/gram (mcg/g) stool and/or absence of inflammation on colonoscopy within 30 and 90 days, respectively, of enrollment
- •Persistent symptoms will be defined by abdominal pain and/or diarrhea T-scores greater than or equal to 55 by the National Institutes of Health (NIH) Patient-Reported outcomes measurement information system Gastrointestinal scale (PROMIS-GI)
排除标准
- •Prior total colectomy
- •Presence of an end ileostomy or colostomy in place
- •Changes in immunosuppressive medications within the past 4 weeks
- •Use of antibiotics or probiotics within the past 4 weeks
- •Active or suspected stricture/stenosis of the GI tract
- •Habitual vegetarian or vegan diet
- •Active or suspected gastrointestinal stricture or stenosis
- •Unable or unwilling to follow a low sulfur diet
- •Patients who are underweight as defined by BMI < 18.5 kg/m2 or have significant unintentional weight loss as defined by >7.5% body weight in the past 3 months
- •Currently pregnant, breastfeeding, and/or unwillingness/inability to use contraception start of the study until the last 13C-mannitol:lactulose test is complete. Sexually active male participants and/or their female partners of reproductive potential must agree to use effective contraception from the start of the study and until the last 13C-mannitol:lactulose test is complete. Women who are breastfeeding must stop breastfeeding during and for at least 12 hours after consuming the 13C-mannitol:lactulose test. Breastfeeding women must pump and dispose of the breastmilk during this time period
- •Subjects must agree to not donate sperm or ova (eggs) or breast milk from the start of the study until the last 13C-mannitol:lactulose test is complete.
结局指标
主要结局
Dietary Protein Intake as assessed by 24 hour diet recall
时间窗: Approximately 16 weeks
Dietary protein intake (animal-based) as assessed by 24 hour diet recall. This is for the group that voluntarily goes on the low sulfur diet after standard of care arm is completed.
Dietary Protein Intake for both groups as assessed by 24 hour diet recall
时间窗: 8 weeks
Dietary protein intake (animal-based) as assessed by 24 hour diet recall
Change in 24 hour urinary sulfate
时间窗: Approximately 16 weeks
Change in 24 hour urinary sulfate level from baseline. This is for the group that voluntarily goes on the low sulfur diet after standard of care arm is completed
Change in 24 hour urinary sulfate
时间窗: 8 weeks
Change in 24 hour urinary sulfate level from baseline
次要结局
- Tolerability of Low Sulfur Diet based on the Visual Analog Scale (VAS)(Approximately 16 weeks)
- Tolerability of Low Sulfur Diet based on the Visual Analog Scale (VAS)(Week 4)
- Tolerability of Low Sulfur Diet based on the Visual Analog Scale (VAS)(Approximately week 12)
- Tolerability of Low Sulfur Diet based on the Visual Analog Scale (VAS)(Week 8)
研究者
Allen Lee
Assistant Professor
University of Michigan