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

NCT02213835 | Completed

• 1 other identifier: SCD001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Crohn's disease and Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 Week

Secondary Outcomes (1)

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

  12 weeks

Other Outcomes (1)

• Stool Microbiome Analysis from baseline and 12 weeks

  12 Weeks

Study Arms (1)

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.

Other: Specific Carbohydrate diet (SCD)

Interventions

Specific Carbohydrate diet (SCD) OTHER

Specific Carbohydrate diet (SCD)

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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, +12.
• Patient must not have medication changes for his/her inflammatory bowel disease medications for at least 1 months, unless medically necessary.

You may not qualify if:

• 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

Sponsors & Collaborators

• David Suskind: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• Suskind DL, Wahbeh G, Gregory N, Vendettuoli H, Christie D. Nutritional therapy in pediatric Crohn disease: the specific carbohydrate diet. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91. doi: 10.1097/MPG.0000000000000103.

  PMID: 24048168 BACKGROUND

• Braly K, Williamson N, Shaffer ML, Lee D, Wahbeh G, Klein J, Giefer M, Suskind DL. Nutritional Adequacy of the Specific Carbohydrate Diet in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):533-538. doi: 10.1097/MPG.0000000000001613.

  PMID: 28825603 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• David L Suskind, MD

  Seattle Children's Hospital and The University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 12, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 24, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)