Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy
研究概览
简要总结
This clinical study protocol aims to prospectively compare the efficacy of standard therapy with anti-TNF agents combined with the Crohn's Disease Exclusion Diet (CDED) versus anti-TNF therapy alone in adult patients with active Crohn's disease or ulcerative colitis.
The study will involve patients starting therapy with anti-TNF agents due to active Crohn's disease or ulcerative colitis as per standard clinical practice and in accordance with European (ECCO) guidelines.
One group will receive standard medical therapy only, the other will additionally receive dietary advice on how to adhere on a specific exclusion diet, the CDED.
By prospectively evaluating the impact of this combined approach, the study seeks to provide evidence on whether CDED can improve response to treatment and therefore improve quality of life for patients with Crohn's disease and ulcerative colitis.
详细描述
This is a prospective interventional, single-center, double-group, open-label study.
Primary objective is to compare the efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy alone.
Secondary objective are:
- Endoscopic response
- Endoscopic remission
- Early and late efficacy and persistence of benefits
- Biochemical response
- Sonographic improvement
- Tolerability and compliance to the Crohn's Disease ExclusionDiet (CDED)
- Quality of life-Safety of the combination of biological therapy and CDED. The subjects considered are adult patients diagnosed with moderate-to-severe Crohn's disease or moderate-to-severe ulcerative colitis who are starting therapy with an approved anti-TNF agent (infliximab and adalimumab for both UC and CD, and golimumab only for UC).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent forparticipation in the study
- •Males or Females, Adults aged 18 years or older
- •Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis
- •Patients who are planned to start anti-TNF therapy
- •Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)
排除标准
- •Patients with undetermined inflammatory bowel disease
- •Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)
- •Patients with a body-mass index lower than 17 or greater than30
- •Patients who previously underwent intestinal resectionirrespective of cause
- •Patients currently on exclusive enteral nutrition (EEN)
- •Patients who have previously used or are currently adhering toCDED
- •Pregnant or breastfeeding women
- •Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED
- •Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant
- •Inability or unwillingness to comply with study protocols orfollow-up schedules
研究组 & 干预措施
Intervention group
Patients who decide independently, after explanation by the PI, to receive dietary advice regarding the CDED diet, will be included in the intervention group.
干预措施: CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy (Combination Product)
Control group
The control group will receive only anti-TNF therapy as per the standard of care and guidelines recommendation
干预措施: Anti-TNF Therapy (Drug)
结局指标
主要结局
Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy
时间窗: Week 14/16
Rate of symptomatic remission (Harvey - Bradshaw Index \<5 for CD or Partial Mayo Score \<2) for UC
次要结局
- Tolerability and compliance to the Crohn's Disease Exclusion Diet (CDED)(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Early and late efficacy and persistence of benefits(Week 6/ Week 24)
- Safety of the combination of biological therapy and CDED(From baseline until the end of the study)
- Endoscopic response and endoscopic remission(Week 24)
- Biochemical response(Week 6, 14/16, 24)
- Sonographic improvement(Week 6, 14/16, 24)
- Quality of life assessed using the Short-IBD-Q questionnaire(Week 14/16, week 24)
研究者
Tommaso Lorenzo Parigi
Gastroenterologist
IRCCS Ospedale San Raffaele