Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Standard of Care or an Adapted Crohn's Disease Exclusion Diet With Partial Enteral Nutrition in Adult Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Improvement of Quality of Life
研究概览
简要总结
Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is on the rise globally. Although medical treatments have advanced, CD still leads to significant health issues due to disease progression and medication side effects. Exclusive enteral nutrition (EEN) is a recommended first-line treatment for pediatric CD, proving more effective than oral corticosteroids without side effects. However, EEN demands strict adherence, making it challenging for patients, particularly adults.
In 2019, Levine et al. found that a combination of a specific diet (CD exclusion diet, CDED) and partial enteral nutrition (PEN) was as effective as EEN in inducing remission in pediatric patients, with better tolerance and adherence. CDED focuses on whole foods and aims to minimize harmful dietary components affecting the gut.
In clinical practice, an adapted CDED (aCDED) has been used to provide more food choices, but it lacks validation in clinical trials. An aCDED that considers regional and seasonal food variations could enhance patient adherence and align with modern dietary preferences.
This study aims to compare the quality of life during a flare up of Crohn's disease treated with standard of care or an adapted Crohn's disease exclusion diet with partial enteral nutrition in adult patients.
详细描述
Crohn's disease (CD), a subgroup of inflammatory bowel disease (IBD), is increasing in incidence worldwide. Despite great advances in medical treatment, CD is associated with considerable morbidity related to progression of the chronic disease and the use of drugs that involve immunosuppression with an associated risk of serious infection as well as malignant and autoimmune sequelae.
Patients with CD often experience malnutrition due to factors like intestinal malabsorption, nutrient loss, restrictive diets, and increased energy expenditure during disease activity. Poor nutrition correlates with reduced treatment response and worse outcomes, emphasizing the significance of assessing and providing nutritional therapy in clinical practice. Additionally, CD is linked to elevated healthcare expenditures, diminished earning potential, comprised health-related metrics, and an overall reduction in quality of life.
In the management of CD, an emerging approach involves the exploration of nutritional interventions as an alternative to conventional therapy, which often entails medication regimes associated with potential side effects and risks.
Dietary therapy by means of exclusive enteral nutrition (EEN), consisting of a liquid formula diet excluding any other oral intake, has been shown to be superior to oral corticosteroids in induction of remission with no medical side effects, and is the recommended first-line treatment in pediatric patients with CD. However, EEN requires a firm commitment from the patients and their social environment to avoid any other oral food intake for 6 to 8 weeks, severely impeding therapy adherence and compliance.
In adult patients a Cochrane review showed a benefit of EEN. However, when the analysis was restricted to high-quality studies only, there was no difference between EEN and corticosteroids. Poor adherence to EEN by adults generally has reduced its utility as a key part of the therapeutic strategy.
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
- Single (Outcomes Assessor)
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
- •Must be ≥ 18 years at the time of signing the informed consent.
- •Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy
- •Patients with a Crohn's disease activity index (CDAI) of ≥ 150
- •Patients will not be excluded if they have received 5ASA or an immunomodulator for > 8 weeks and the dose is stable, or if they start a thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
- •Able to adhere to the study visit schedule and other protocol requirements
- •All subjects must agree to refrain from donating blood while on study drugs
- •All subjects must agree not to share medication.
- •Subject (male or female) is willing to use highly effective contraceptive methods during treatment and for 28 days (male or female) after the end of treatment
排除标准
- •Patients with with minimal disease activity (CDAI <150) or severe disease (CDAI >450)
- •Patients who have received corticosteroids of any kind in the previous 4 weeks
- •Patients who have started an immunomodulator in the previous 8 weeks
- •Any current biological or small molecule treatment
- •Isolated large bowel disease iinvolving the recto-sigmoid or descending colon
- •Patients with penetrating disease (abscess or fistula)
- •Active perianal disease
- •Fixed stricture or small bowel obstruction
- •Normal fecal calprotectin
- •Active extraintestinal disease (e.g. joint disease)
- •Patients who have undergone an intestinal resection
- •Sclerosing cholangitis
- •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- •Women during pregnancy and lactation Participation in other clinical trials or observation period of competing trials.
研究组 & 干预措施
Standard of care
Prednisolone
干预措施: Prednisolone (Drug)
Interventional arm
Adapted Crohn's disease Exclusion Diet (aCDED)
干预措施: aCDED + Modulen (Dietary Supplement)
结局指标
主要结局
Improvement of Quality of Life
时间窗: 12 weeks
Measuring Quality of Life (QoL) using the IBD-Q-32-questionnaire (Inflammatory Bowel Disease Questionnaire with 32 items) * measuring the relative improvement compared to baseline * Minimum score: 32 points = bad QoL * Maximum score: 224 points = excellent QoL
次要结局
- Alterations in the microbiome in responders vs non-responders(12 weeks)
- Alterations in the metabolome in responders vs non-responders(12 weeks)
- Alterations in the intestinal immune profile in responders vs non-responders(12 weeks)
- Measuring mucosal inflammation(12 weeks)
- Reduced fecal calprotectin(week 12 and 24)
- Patients' adherence to the diet assessed by cessation of therapy because of patients' refusal to continue and by a questionnaire(12 weeks)
- Improvement of markers of malnutrition compared between the treatment arms(12 weeks)
- Remission (defined as CDAI≤150)(weeks 6, 12 and 24)
- Link between genetic risk, microbiome, metabolome, intestinal immune profile and therapy outcome(12 weeks)
- Measuring adverse events from steroid therapy(12 weeks)