Einfluss Ballaststoffreicher Ernährung Auf Das Mikrobiom Und Die Krankheitsaktivität Von Patientinnen Und Patienten Mit Rheumatoider Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Short-Chain Fatty Acids (SCFA) Levels in Stool
研究概览
简要总结
The goal of this clinical trial is to learn if increasing dietary fiber can improve the gut microbiome and reduce disease activity in adults with rheumatoid arthritis (RA). The main questions it aims to answer are:
- Can a higher fiber diet improve gut bacteria and produce beneficial short-chain fatty acids (SCFAs)?
- Does a higher fiber diet reduce RA symptoms and help with weight loss?
Researchers will compare two groups: one group will receive dietary counseling and take 10 grams of psyllium husk daily, while the other group will continue their usual diet.
Participants will:
- Complete dietary questionnaires at the start, 6 months, and 12 months.
- Provide stool samples for gut bacteria and SCFA analysis.
- Have their RA activity and body weight monitored regularly.
- Receive regular phone calls to support the dietary changes.
The study will involve adults with diagnosed RA who can provide informed consent and meet other inclusion criteria.
详细描述
Background and Rationale:
Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic inflammation of the joints. Emerging evidence indicates that the gut microbiome plays a crucial role in immune system modulation and may influence the development and progression of RA. Dietary fibers are known to enhance the production of short-chain fatty acids (SCFAs) by gut bacteria, which in turn can have beneficial effects on the immune system. Studies have shown that SCFAs can prevent the onset of RA in animal models and reduce disease activity in humans at risk. Additionally, a fiber-rich diet has been associated with weight loss, which is beneficial for RA patients as lower body weight is linked to reduced disease activity. Despite recommendations from the German Society for Nutrition to consume 30 grams of dietary fiber daily, most individuals fail to meet this target.
Study Objectives and Hypotheses:
The primary objectives of this study are to:
- Investigate the gut microbiome of patients with established RA and its relationship with disease activity and body weight.
- Assess whether increasing dietary fiber intake can favorably modify the gut microbiome and increase SCFA production.
- Determine the impact of a fiber-rich diet on RA disease activity and body weight over a 12-month period.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Diagnosis of Rheumatoid Arthritis according to the ACR criteria of 2010
- •The patient can understand the scope of the study and consents in writing to participate.
排除标准
- •Age under 18
- •Lack of consent capability
- •Insufficient knowledge of the German language
- •Chronic inflammatory bowel disease
- •Liver cirrhosis
- •History of mechanical ileus
- •Patients with altered gastrointestinal passage (e.g., stoma patients)
- •Use of antibiotics within the past three months
- •Use of ground psyllium husks four weeks prior to study inclusion
结局指标
主要结局
Short-Chain Fatty Acids (SCFA) Levels in Stool
时间窗: Measurements will be assessed at baseline, 6 months, and 12 months.
The concentration of short-chain fatty acids (SCFAs) in stool samples will be measured. SCFAs, such as acetate, propionate, and butyrate, are produced by the gut microbiota through the fermentation of dietary fibers. These compounds play a crucial role in maintaining gut health and modulating the immune system. The levels of SCFAs will be analyzed to determine the impact of increased dietary fiber intake on gut microbiota composition and function.
Disease Activity Score 28 (DAS28)
时间窗: Measurements will be assessed at baseline, 6 months, and 12 months.
The Disease Activity Score 28 (DAS28) is a composite measure used to assess the activity of rheumatoid arthritis (RA). It is calculated using the number of tender and swollen joints (out of 28 specified joints) and the patient's global health assessment. The DAS28 score ranges from 0 to 9.4, with higher scores indicating higher disease activity. This measure is widely used in clinical practice and research to monitor and evaluate the effectiveness of RA treatments.
Body Weight
时间窗: Measurements will be assessed at baseline, 6 months, and 12 months.
Participants' body weight will be measured to assess changes over the study period. Weight measurements will be taken using a standardized and calibrated scale. Changes in body weight will help determine the effect of increased dietary fiber intake on weight management in individuals with rheumatoid arthritis.
C-Reactive Protein (CRP) Level
时间窗: Measurements will be assessed at baseline, 6 months, and 12 months.
C-reactive protein (CRP) level is a biomarker used to measure inflammation in the body. Elevated CRP levels are indicative of inflammation and are commonly seen in rheumatoid arthritis patients. CRP levels will be measured using blood tests to assess the inflammatory status of the participants.
次要结局
- Changes in Gut Microbiome Composition(Measurements will be assessed at baseline, 6 months, and 12 months.)
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(Measurements will be assessed at baseline, 6 months, and 12 months.)
- Patient Global Assessment of Disease Activity(Measurements will be assessed at baseline, 6 months, and 12 months.)
- Erythrocyte Sedimentation Rate (ESR)(Measurements will be assessed at baseline, 6 months, and 12 months.)