Modified vs Standard Crohn´s Disease Exclusion Diet: Evaluation of a Nordic Adaptation of Nutritional Therapy in Paediatric Crohn's Diseas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Corticosteroid-free Clinical Remission
研究概览
简要总结
The primary aim of this clinical trial is to evaluate the clinical effectiveness of the Nordic Crohn's Disease Exclusion Diet (Nordic CDED) in children with Crohn's disease, measured by remission rates, and to compare these outcomes with those reported for the original CDED in similar pediatric populations and study designs.
The secondary objectives are to assess whether the Nordic CDED can facilitate greater individualization of the diet, improve treatment adherence, and enhance quality of life.
The study seeks to answer the following key questions:
- Does the Nordic CDED achieve the same clinical effectiveness as the original CDED?
- Does the Nordic CDED improve adherence and quality of life in children with Crohn's disease? To address these questions, researchers will compare outcomes from children following the Nordic CDED with published results from similar studies of the original CDED, as well as with patients who were not treated with a dietary intervention.
Participant Involvement:
- Follow the Nordic CDED for 20 weeks.
- Attend clinic visits at weeks 2, 8, 14, 20, and 24 for checkups and tests.
- Report adherence to the diet through food records.
- Report quality of life at the beginning and end of the study
详细描述
The aim of this study is to investigate whether a Nordic version of the Crohn's Disease Exclusion Diet (Nordic CDED) is as effective in achieving clinical remission as the original version of the diet (CDED), which was developed by Levin A et.al. in 2019.
The primary objective is to compare the clinical effect - in terms of remission rates - between Nordic CDED and results from studies where the original CDED has been used in similar patient groups with comparable methodology.
The secondary objective is to evaluate if a Nordic adaptation of the CDED may facilitate individualization and improve adherence and quality of life in paediatric patients with Crohn's Disease.
Overview of the field Crohn's Disease (CD) has increased in prevalence worldwide over the past decades, particularly among children and young people. In Northern Europe, the prevalence is among the highest in the world, with approximately 0.13% of the population living with Crohn's disease. This disease not only causes significant personal suffering and reduced quality of life for affected individuals but also leads to increased healthcare costs. Additionally, it has a major impact on patients' dietary habits, social lives, and self-image. Research has not yet fully clarified why CD develops, but it appears to involve a complex interaction between genetic factors, the immune system, gut microbiota, and environmental influences - with diet playing an increasingly important role.
In the 1990s, exclusive enteral nutrition (EEN), consisting of 6-8 weeks on a liquid diet, was shown to induce remission in patients with mild to moderate active CD. While the underlying mechanism of EEN remains unknown, it has been proposed to favourably modulate the gut microbiome, the intestinal barrier function and immunity. In children with mild to moderate CD, EEN remains the first-line treatment recommended by the European Crohn's and Colitis Organization (ECCO), the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), and the Swedish national guidelines. Therefore, this remains a common first-line treatment in the Swedish health-care setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-18 years with recent (<36 months) mild-to-severe CD diagnosis (defined as Paediatric Crohn's Disease Activity Index [PCDAI] 15-47.5)
- •Evidence of active inflammation (C-reactive protein [CRP] ≥ 0.5 mg/dL, erythrocyte sedimentation rate [ESR] ≥ 20 mm/h, and/or faecal calprotectin [FCP] ≥ 200 mg/g during screening)
- •Stable use of medication other than steroids.
排除标准
- •Eating disorders,
- •Active extraintestinal manifestations
- •Use of systemic corticosteroids
- •Active perianal disease
- •Positive stool cultures for pathogens, parasites, or Clostridioides difficile
- •Fever >38.3°C
- •Documented cow's milk protein allergy
- •Diabetes, celiac disease and/or psychosocial difficulties.
研究组 & 干预措施
Nordic Crohn´s Disease Exclusion Diet
2 weeks of total enteral nutrition followed by 3 phases (6 weeks each) of a Nordic Crohn´s Disease Exclusion Diet.
干预措施: Nordic Crohn´s Disease Exclusion Diet (Other)
结局指标
主要结局
Corticosteroid-free Clinical Remission
时间窗: From enrollment to week 8,14 and 24
Measured by remission rates: PCDAI ≤10 without systemic steroid use, of the Nordic CDED compared to same outcome from studies of the original CDED in similar paediatric populations and study designs. Tool: PCDAI, a validated tool used to measure the severity of Crohn's disease in children and adolescents by scoring various clinical and laboratory factors Symptoms: Abdominal pain, frequency/consistency of stools, blood in stool. Growth: Weight stability and linear growth (height velocity). Physical Exam: Presence of perianal disease (fistulas, fissures) and extra-intestinal manifestations (arthritis, uveitis, skin issues). Lab Tests: Hemoglobin, hematocrit, ESR (Erythrocyte Sedimentation Rate).
次要结局
- Corticosteroid-free clinical remission(At week 8, 14, 20 and 24)
- Additional medical treatment(At week 14 of treatment)
- Reduction in Faecal calprotectin(By week 20 and 24 of the study.)
- Adherence to N-CDED diet(Week 2, 8, 14 and 24)
- Modification in quality of life(Basal, week 8 and 24)