Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions--Aim 1: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 20
- 主要终点
- Fecal Calprotectin
研究概览
简要总结
A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis (IC)
- •Age 7-18 years
- •Enrolled in the ImproveCareNow (ICN2) registry
- •Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment.
- •Potential participants who are close to meeting one of the acute inflammation and/or elevated acute phase reactant markers and who meet all other study criteria will be considered for study participation on a case by case basis by the investigative study team in consultation with the patient's primary gastroenterologist.
排除标准
- •Complex and Unstable IBD:
- •Currently or within the past 9 months has had an abscess, fistula, stricturing CD, or ostomy
- •Severe disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of >45 or Pediatric Ulcerative Colitis Activity Index (PUCAI) score of >60 assessed within three weeks of enrollment
- •Ever had history of full colectomy
- •Hospitalization or surgery planned within 3 months
- •Ongoing active gastrointestinal infection
- •Severe Malnutrition (BMI less than 5th percentile)
- •Recent medication changes including:
- •Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to enrollment
- •Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment
- •Vedolizumab started within 16 weeks prior to enrollment
- •Increase in corticosteroids within 4 weeks of screening or have dose >20 mg prednisone or equivalent
- •Evidence of Other Complicating Medical Issues:
- •Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
- •Serious psychological or psychiatric conditions such as eating disorders or self-harm
- •Pregnancy
- •Tobacco, alcohol, or illicit drug abuse
- •Inability to Complete the Protocol
- •Non-English speaking participants
- •On SCD or modified SCD anytime within 8 weeks of enrollment
- •If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of enrollment but they are noncompliant per the determination of the patient's dietitian/primary gastroenterologist, then this patient is eligible to participant in the study.
- •Participants on a vegan diet
- •Lack of smart phone and data plan for participating caregiver
- •Participating in another concurrent intervention study
研究组 & 干预措施
Specific Carbohydrate Diet (First)
Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey.
干预措施: Specific Carbohydrate Diet (SCD) (Other)
Specific Carbohydrate Diet (First)
Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey.
干预措施: Modified Specific Carbohydrate Diet (MSCD) (Other)
Modified Specific Carbohydrate Diet (First)
Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted.
干预措施: Specific Carbohydrate Diet (SCD) (Other)
Modified Specific Carbohydrate Diet (First)
Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted.
干预措施: Modified Specific Carbohydrate Diet (MSCD) (Other)
结局指标
主要结局
Fecal Calprotectin
时间窗: At baseline and once at the end of each treatment period (weeks 10, 18, 26 and 34) for a total of 5 times
Laboratory measurement of intestinal inflammation. Stool will be collected by participants at home and will be mailed to a central lab for processing and analysis.
Stool frequency
时间窗: Daily through study completion (34 weeks from randomization)
Self-reported number of stools per day entered as an integer in the study mobile app
Pain Interference
时间窗: Weekly through study completion (34 weeks from randomization)
Patient reported outcome of pain interference measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale on the study app. The scale includes 8 items and responses to each item are on a 0 (Never) to 4 (Almost Always) scale. Higher scores indicate greater pain interference. Look up tables provided by the PROMIS Assessment Center will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
Stool Consistency
时间窗: Daily through study completion (34 weeks from randomization)
Self-reported assessment of stool consistency using the Bristol Stool Scale entered in the study mobile app
Gastrointestinal Symptoms
时间窗: Weekly through study completion (34 weeks from randomization)
Self-reported outcome of GI symptom burden measured using the PROMIS GI Symptoms scale on the study app. The scale includes 4 items and responses to each item are on a 1 (Never) to 5 (Almost Always) scale. Higher scores indicate greater GI symptom burden. Look up tables provided by the measure developers will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
次要结局
- Provider measured disease activity(At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization))
- Growth(At baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization))
- Laboratory markers of disease activity and inflammation(At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization))
- Short Crohn's Disease Activity Index (sCDAI)(Weekly through study completion (34 weeks from randomization))
- Pediatric Ulcerative Colitis Activity Index (PUCAI)(Weekly through study completion (34 weeks from randomization))