SSc-DIGEST Trial: Systemic Sclerosis DIet for GastrointESTinal Symptoms Randomized Controlled Trial of Low FODMAP, CDED, and NICE Diets for Gastrointestinal Symptoms in Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Bloating severity
研究概览
简要总结
This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Following the research specifics of the diets will be available upon contact with the details listed below.
详细描述
The rationale for keeping the diets (arms/interventions names) vague is it prevents other researchers from using these diets in their studies, minimizes expectation bias of patients (who can have preference for one diet over other) and prevents participants from trying other diets before end of study period in case they don't respond.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the dietary counseling intervention, it will not be possible to blind dietitians and participants. Participants will be aware of general participation in dietary therapy but blinded to specific diet names. Investigators, outcome assessors, and the biostatistician will be fully blinded to allocation.
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
- •Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria
- •.• Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score ≥2.00 on (0.00-3.00 scale) at screening.
- •Willingness and ability to comply with dietary intervention and study procedures.
- •Ability to provide informed consent.
排除标准
- •Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease.
- •Use of systemic antibiotics within 4 weeks prior to baseline.
- •History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months).
- •Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions.
- •Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework.
- •Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.).
- •Clinically significant self-reported (≥10 percent weight loss) in the last 3 months
- •BMI less than 20
- •Ongoing tube feeds or TPN
- •Participating in another interventional trial
- •Pregnancy or lactation, or planning pregnancy in the next 6 months
研究组 & 干预措施
Diet 3: Regular meal patterns, soluble fiber, and portion control
干预措施: Diet 3: Regular meal patterns, soluble fiber, and portion control (Behavioral)
Diet 1: Restriction of fermentable carbohydrates
干预措施: Diet 1: Restriction of fermentable carbohydrates (Behavioral)
Diet 2: Elimination of foods harmful to gut barrier and microbiome
干预措施: Diet 2: Elimination of foods harmful to gut barrier and microbiome (Behavioral)
结局指标
主要结局
Change in Bloating severity
时间窗: Baseline to week 6
As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.1 - Gastrointestinal Gas and Bloating 13a - 13 questions with raw summed scores ranging from 13-36.
次要结局
- Change in Bloating severity(Baseline to week 6)
- Change in Abdominal pain severity(Baseline to week 6)
- Change in Overall GI symptom(Baseline to week 6)
研究者
Dinesh Khanna, MD, MS
Frederick G L Huetwell Professor of Rheumatology, Professor of Internal Medicine and Program Director, Internal Medicine, Medical School
University of Michigan