Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical Remission
研究概览
简要总结
The primary objective of this study is to determine the efficacy of a novel enteral nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD).
The hypothesis is that no significant difference in the remission rate between the novel EN protocol with partial enteral nutrition (PEN) and standard protocol with EEN will be observed.
详细描述
Background: Exclusive enteral nutrition (EEN) is a well established method of treatment for inducing remission in childhood-onset Crohn's disease. It involves placing children on a strict diet composed only of a single polymeric formula, as the sole source of nutrition over 6 to 8 weeks. Use of this treatment method results in clinical remission in 50% to 80% of children by week 6-8.
Partial enteral nutrition (PEN) would be more acceptable to patients than EEN, and might be an effective treatment for active Crohn's disease. Moreover, there are studies suggesting that PEN may be effective for the induction of remission in pediatric patients with Crohn's disease; however, the level of evidence is still low.
Methods: This is a prospective randomized controlled trial, in patients with active childhood-onset Crohn's disease comparing two arms over 6 weeks of therapy.
Group 1 (PEN group): will receive 75% of their dietary needs from a polymeric formula (Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) whole food AID-CD for 6 weeks.
Group 2 (EEN group): will receive EEN with Alicalm (Nutricia) for 6 weeks.
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
- 4 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (4 - 18 years of age)
- •Young adults (>18 and ≤ 30 years of age) with childhood-onset CD (the diagnosis of CD before 18 years of age)
- •Assured diagnosis of Crohn's disease according to the Porto criteria
- •Patients with Active CD (Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 in children or Harvey-Bradshaw Index (HBI) >3 in young adults )
- •Patients with new-onset CD and patients with active disease despite stable doses of concomitant therapy with immunomodulators (thiopurines, methotrexate, tacrolimus) for ≥ 3 months, on stable doses of biologic therapy (anti-TNF-a agents) for ≥ 2 months
- •Patients will not be excluded if they start therapy with thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks
- •Written consent of the patient and/or the legal guardian
排除标准
- •Patients with no disease activity ( PCDAI <10)
- •Patients who have received corticosteroids of any kind in the previous 4 weeks.
- •Patients with penetrating disease (abscess or fistula)
- •Active Perianal disease
- •Active Extraintestinal disease
- •Sclerosing Cholangitis
- •Patients with fixed stricture or small bowel obstruction
- •If the patients had received any other medication for inducing remission such as steroids and/or antibiotics
- •No consent of the patient and/or the legal guardian
结局指标
主要结局
Clinical Remission
时间窗: 6 weeks
Clinical Remission (Pediatric Crohn's Disease Activity Index \<10) on an intention to treat principle after 6 weeks of therapy.
次要结局
- Clinical response(6 weeks)
- Changes in stool calprotectin concentrations(At the 3 and 6 weeks visits)
- Mucosal healing(6-8 weeks)
- Change in SES-CD(At week 0 and 6 -8 weeks following enrollment)
- Changes in specific blood tests(At the 1, 3 and 6 weeks visits)
- Changes in weight-z-scores(At the 0 and 6 weeks visits)
- Changes in ITM -z-scores(At the 0 and 6 weeks visits)
研究者
Darja Urlep
Principal investigator
University Medical Centre Ljubljana