Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Number of Participants With Clinical Remission for Crohn's Disease
研究概览
简要总结
There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).
详细描述
The investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune paleo (AIP) diet in patients with Crohn's disease (CD) and ulcerative colitis (UC).
Specific aims:
- To evaluate the effect of the AIP diet on clinical and endoscopic disease activity for CD and UC,
- To examine changes in inflammatory biomarkers during AIP diet
- To characterize changes in RNA expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study.
- To characterize changes in fecal microbiome during diet intervention
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
- •Established diagnosis of small bowel CD or colonic CD or ulcerative colitis
- •Confirmation of active CD or UC with recent (within 6 months of consent or prior to study start) objective evidence of endoscopically active disease on colonoscopy or computed tomography/magnetic resonance enterography or video capsule endoscopy
- •Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
- •Current disease activity defined as a Harvey Bradshaw index ≥ 5 at baseline for CD or Partial Mayo Score ≥ 3 for UC
- •Established Facebook account
- •Comfortable with internet-based surveys and email
排除标准
- •If female, is pregnant or is breast feeding
- •Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
- •Inability to provide informed consent or unwilling to participate
- •Evidence of untreated infection (e.g. Clostridium difficile)
- •Presence of stoma or J pouch
- •Bowel surgery within 12 weeks prior to enrollment and/or has surgery planned or deemed likely for inflammatory bowel disease during the study period
- •Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 4 weeks prior to study initiation
研究组 & 干预措施
Autoimmune protocol (AIP) diet
Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy
干预措施: Autoimmune protocol (AIP) diet (Other)
结局指标
主要结局
Number of Participants With Clinical Remission for Crohn's Disease
时间窗: 11 weeks
Clinical disease activity scores will be measured by Harvey Bradshaw Index for patients with Crohn's Disease (CD). The Harvey Bradshaw Index measures general well being, abdominal pain severity, number of stools daily, presence of abdominal mass, and complications. The Harvey Bradshaw Index ranges from 0-16, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Harvey Bradshaw Index \<5 for CD.
Number of Participants With Clinical Remission for Ulcerative Colitis
时间窗: 11 weeks
Clinical disease activity scores will be measured by Mayo score for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. The Mayo score ranges from 0-12, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Mayo score 2 or less for UC.
次要结局
- Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis(11 weeks)
- Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention(11 weeks)
- Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention(11 weeks)
- Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes(11 weeks)
- Changes in Fecal Microbiome Composition During Dietary Intervention(11 weeks)
研究者
Gauree G. Konijeti
Physician, Clinical Investigator
Scripps Health