Nutritional Therapy Study in Pediatric Crohn's Disease

NCT02610101 | Completed DMC

• 1 other identifier: IRB#15606
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Crohn's Disease (CD). The SCDiet is a diet where all grains such as wheat, barley, corn, rice are restricted. Most dairy products (except certain yogurt) are also restricted. The diet mainly consists of meat, fruits, vegetables, nuts, oils and honey, and is offered to individuals with active Crohn's disease as part of standard of care at Seattle Children's. For this study, the investigators will have three different dietary groups:

• Is the SCD well tolerated?
• Is SCD effective for the treatment for active Crohn's Disease?
• Will the results from the varied three dietary groups have the same results for each patient?

Conditions

Crohn's Disease

Keywords

Specific Carbohydrate Diet; Diet; Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in Pediatric Crohn's Disease Activity Index

  Activity Index is a validated form of measurement for disease activity

  12 weeks

Secondary Outcomes (3)

• Fecal Microbiome Analysis

  12 weeks

• Change in C-reactive protein at Baseline and 12 weeks

  12 weeks

• Change in Calprotectin at Baseline and 12 weeks

  12 weeks

Study Arms (3)

Traditional SCD Diet

ACTIVE COMPARATOR

7 subjects will be randomized to a traditional SCD diet

Other: Traditional SCD Diet

Modified SCD Diet

ACTIVE COMPARATOR

7 subjects will be randomized to a "modified SCD diet", which includes oatmeal and rice

Other: Modified SCD Diet

Whole Foods Diet

ACTIVE COMPARATOR

7 subjects will be randomized to a" Whole foods diet" without added sugars

Other: Whole foods diet

Interventions

Traditional SCD Diet OTHER

Traditional SCD includes removal of all processed foods as well as all grains, sweetners except for honey and all diary except for yogurt fermented for over 24hrs and some hard cheeses

Also known as: SCD

Traditional SCD Diet

Modified SCD Diet OTHER

Food components of the traditional SCD with the addition of rice and oats.

Also known as: Modified SCD

Modified SCD Diet

Whole foods diet OTHER

A whole foods diet with removal of processed foods. Removal of corn, wheat, sugar and milk are also apart of this dietary regime.

Whole Foods Diet

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents 8 to 21 years old
• Diagnosis of 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)
• 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
• Active or history of intra abdominal abscess, intra abdominal 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

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal 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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)