Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet ("CDED") for Ileal Pouch Anal Anastomosis ("IPAA") Patients With Endoscopic Deterioration or Clinically Suspected Pouchitis
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- steroid free clinical remission
研究概览
简要总结
Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for patients with ulcerative colitis (UC) who require surgery. Inflammation of the ileal pouch (pouchitis) occurs in up to 60% of pouch patients.
Although, pouchitis patients are former UC patients, the disease occurs in the small intestine, similarly to Crohn's disease (CD). Further, the disease can be clinically similar to CD, involving the proximal gastro-intestinal tract and causing strictures, fistula, or perianal disease.
The Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. The diet also provides dietary components that may favor species (especially SCFA producers) which appear to be deficient in CD.
The investigator therefore aims to examine the microbial, mucosal and immunological changes of the pouch during one year post IPAA, and examine the impact of the CDED on disease activity and dysbiosis in a cohort of adults suffering from active pouchitis.
详细描述
Hypothesis (es) and Aims:
- The investigator aims to evaluate the natural development of the pouch microenvironment among post-IPAA patients over one year of follow-up, and associate dietary intake with shaping the pouch microbiome composition, metabolic activity, proteolytic activity and with development of pouchitis.
The investigator hypothesizes that the different dietary pattern of post-IPAA patients will be associated with different pouch microenvironments, and with the development of pouchitis. 2. The investigator aims to measure the effect of the CDED on shaping the pouch microenvironment among post-IPAA patients over one year of follow-up, compared with a control standard diet. The investigator further aims to assess if the CDED is an effective mean of prevention of pouchitis in post-IPAA patients.
The investigator hypothesizes that adherence to the CDED post-IPAA will positively effect the pouch microbiome composition, metabolic activity and proteolytic activity, and be an efficient means to maintain surgical remission in pouch patients, compared with a control standard diet. 3. The investigator aims to evaluate the effect of the CDED on acute pouchitis activity compared with a control-standard diet.
The investigator hypothesizes that the CDED will induce clinical, biological and endoscopic remission in pouchitis patients, and that remission will be maintained through 24 weeks. Results are expected to show superiority over a standard diet for clinical remission in pouchitis patients. 4. The investigator aims to examine whether changes in circadian rhythm are associated with improvement in clinical and biological disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Post-IPAA for ulcerative colitis ≤3 months post-opp OR post -IPAA for UC 1.1 Active pouchitis defined as: 1.1.1 ≥5 points modified Pouch disease activity index (mPDAI), and one of the following: 1.1.2 Pouchoscopy demonstrating lesions in the ileum/jejunum/afferent pouch loop of the pouch, clinical PDAI>2 points 1.1.3 MR/CTEnterography with evidence of inflammation of the pouch 1.1.4 Fecal calprotectin>250 µg/gr
- •Lack of obstructive symptomes for 8 weeks
- •Stable medications and doses:
- •3.1 Immunomodulatory and biologics at least 8 weeks 3.2 Mesalamine at least 4 weeks 3.3 Medical cannabis at least 2 weeks 3.4 Budesonide dependent allowed if patients are active and budesonide dose is ≤6 mg, VIVOMIX probiotics allowed). Use of Antibiotics / Budesonide <6 mg at baseline*.
- •*Patients treated with steroids or antibiotics at baseline will be included in the study and be allowed to continue the study if they treated with a stable dose throughout at least 4 weeks. After 4 weeks if the trial, if they present clinical improvement, according to the judgment of the study physician, dose may be gradually reduced for the remaining trial without exclusion.
- •Informed consent and ability to complete the study protocol.
排除标准
- •Use of systemic steroids / Budesonide >6 mg at baseline.
- •Currently active systemic diseases such as spondylo-arthropathies, collagen vascular disease, renal failure, hepatitis or heart disease
- •Positive Stool culture, stool parasites or clostridium difficile toxin or alternative C- Difficile test.
- •Evidence of bowel stricture
结局指标
主要结局
steroid free clinical remission
时间窗: week 6
defined as Clinical pouchitis disease activity index ("cPDAI" ranges between 0-6 where highest is the worst and lowest is best clinically) sub score≤2 for pouchitis patients
次要结局
- Clinical response(week 12)
- Pouchitis remission(week 24)
- Clinically significant change in mean fecal calprotectin(week 24)
- Steroid free clinical remission(week 12)
- Maintenance of clinical remission(week 24)
- Clinically significant change in mean CRP(week 24)
- clinical and endoscopic remission(week 24)
研究者
Eli Sprecher, MD
PI
Tel-Aviv Sourasky Medical Center