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临床试验/NCT02213835
NCT02213835已完成不适用

Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis

David Suskind2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
试验地点
2
主要终点
Change in Pediatric Crohn's disease Activity Index/Pediatric Ulcerative Colitis Activity Index at baseline and 12 weeks

研究概览

简要总结

The aim of this study is to determine the tolerability and potential efficacy of dietary therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with Crohn's disease (CD) and Ulcerative Colitis (UC). This is a single center, open labelled study designed to determine tolerability, preliminary safety and potential efficacy in pediatric patients with CD and UC. The study patients will be recruited from Seattle Children's GI clinic. the investigators will enroll 10 patients with mild to moderate CD (defined as PCDAI score of 10-29) or Ulcerative colitis (PUCAI 10-60) ages 8 to 21 years. Each patient will be in the study for approximately 12 weeks.

详细描述

Ten patients with CD or UC with mild or moderate disease activity as defined by Pediatric Crohn's disease activity index (PCDAI score of 10-29 or PUCAI of 10 - 60) aged 8 -21 years will enroll into this study. Each patient will receive an initial evaluation including a physical exam, medication review, nutritional guidance and post treatment evaluations.

Initial evaluation: Study subject recipient will have the following lab tests including CBC with differential & platelets, a c-reactive protein, sedimentation rate, an albumin, vitamin D level, a stool study for c. difficile, for bacterial culture and ova and parasite, stool calprotectin and microbiome. Additionally, the investigators will complete a physical exam and document their current medications. The study nutritionist will complete a thorough diet history.

Treatment: The treatment for this study will be the Specific Carbohydrate diet (SCD). Intervention will be based upon standard dietary therapy as well as a nutritional handbook developed in the Gastroenterology division. Patients will receive one-on-one guidance by a Seattle Children's Dietician trained in the SCD during each visit. Prior to each visit patient will fill out a 3 day nutrition log which will be reviewed by the dietician during the clinic visit. Each patient will receive books on the SCD therapy which will include recipes and information about the diet The two books given will include "Breaking the Vicious Cycle" by Elaine Gottschall and "Recipes for the Specific Carbohydrate Diet" by Raman Prasad.

Follow-up: Each study subject will have clinical follow-up at 2 weeks, 4 weeks, 8 weeks and 12weeks. Standardized questionnaires, including the Pediatric Crohn's disease activity index (PCDAI) or Pediatric Ulcerative colitis activity index (PUCAI) will be completed during each study visit. Information about tabulating the PCDAI/PUCAI scores is listed in Appendix A. In addition patients will have a physical exam and standard blood work including CBC, sedimentation rate, C-reactive protein, albumin and stool for microbiome analysis at each follow up visit. This stool will be sent to the University of Washington (Dr. Sam Miller's lab) for analysis. Stool calprotectin will additionally be done at week 4 and 12. Vitamin D level will be measured at week 12. Finally, all patients will meet with the nutritionist at each visit who will complete a thorough diet review. Any questions about the SCD will be addressed at each visit.

All study related information will be stored in the RedCap database. Participant data for the study will be stored electronically in the REDCap platform. The REDCap platform is managed by the Institute for Clinical and Translational Science at the University of Washington. Only IRB approved research team members will have access to the REDCap data platform. Each team member will be granted access to the REDCap data system through a secure login. The information about each participant will be de-identified using a unique study code. Some personal information such as date of birth will be stored in RedCap.

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
8 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents eight to twenty one years old
  • Diagnosis of Ulcerative colitis or Crohn's Disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology
  • Mild or moderate disease activity based upon PCDAI score (10-45) or PUCAI score (10-60)
  • Parent/guardian and child must be able to comprehend the consent and assent
  • Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +
  • Patient must not have medication changes for his/her inflammatory bowel disease medications for at least 1 months, unless medically necessary.

排除标准

  • Severe disease with PCDAI >45 or PUCAI >60
  • Active or history of intraabdominal abscess, intraabdominal fistula, stricturing Crohn's disease
  • Other serious medical conditions such as neurological, liver, kidney, autoimmune or systemic disease.
  • Has begun TNF inhibitors within two months prior to study
  • Has had change of maintenance medication within the last month
  • Tobacco, alcohol or illicit drug abuse
  • Pregnant subject recipients will be excluded

研究组 & 干预措施

Specific Carbohydrate diet (SCD)

Experimental

The treatment for this study will be the Specific Carbohydrate diet (SCD). Intervention will be based upon standard dietary therapy as well as a nutritional handbook developed in the Gastroenterology division. Patients will receive one-on-one guidance by a Seattle Children's Dietician trained in the SCD during each visit. Prior to each visit patient will fill out a 3 day nutrition log which will be reviewed by the dietician during the clinic visit. Each patient will receive books on the SCD therapy which will include recipes and information about the diet The two books given will include "Breaking the Vicious Cycle" by Elaine Gottschall and "Recipes for the Specific Carbohydrate Diet" by Raman Prasad.

干预措施: Specific Carbohydrate diet (SCD) (Other)

结局指标

主要结局

Change in Pediatric Crohn's disease Activity Index/Pediatric Ulcerative Colitis Activity Index at baseline and 12 weeks

时间窗: 12 Week

Pediatric Crohn's disease Activity Index/Pediatric Ulcerative Colitis Activity Index are validated measures of disease activity for pediatric Crohn's disease and ulcerative colitis respectively.

次要结局

  • Change of common Laboratory measures including Complete Blood Count, sedimentation rate, C-Reactive Protein, stool Calprotectin at baseline and 12 weeks(12 weeks)

研究者

发起方
David Suskind
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Suskind

Professor of Pediatrics

Seattle Children's Hospital

研究点 (2)

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