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Summary

for people ages 7–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a three-year study. The study staff will recruit 120 patients (goal sample size of 100, accounting for attrition) across up to 12 sites in patients aged 7-17 with mild to moderate disease activity.

Official Title

Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions--Aim 1: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

Keywords

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Colitis Ulcer Colitis, Ulcerative

Eligibility

You can join if…

Open to people ages 7–17

  • Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis(IC)
  • Age 7-17 years
  • Enrolled in the ImproveCareNow (ICN2) registry
  • Mild to moderate disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of 15-45 or Pediatric Ulcerative Colitis Activity Index(PUCAI) score of 10-60 at baseline; and
  • Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 2 times the upper limit of normal, CRP 1.25 times the upper limit of normal, or ESR 1.25 times the upper limit of normal (based on local reference ranges) within 8 weeks of enrollment.

You CAN'T join if...

Complex and Unstable IBD:

  • Past or present history of intra-abdominal abscess, fistula, stricturing CD, or ostomy
  • Hospitalization or surgery planned within 3 months
  • Ongoing active gastrointestinal infection
  • Moderate or Severe Malnutrition (BMI less than 10th percentile)
  • Recent medication changes including:
  • Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to enrollment
  • Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment
  • Vedolizumab started within 16 weeks prior to enrollment
  • Increase in corticosteroids within 4 weeks of screening or have dose >20 mg prednisone or equivalent

Evidence of Other Complicating Medical Issues:

  • Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
  • Serious psychological or psychiatric conditions such as eating disorders or self-harm
  • Pregnancy
  • Tobacco, alcohol, or illicit drug abuse

Inability to Complete the Protocol

  • Non-English speaking participants
  • On SCD or modified SCD anytime within 8 weeks of enrollment
  • Participants on a vegan diet
  • Lack of smart phone and data plan for participating caregiver
  • Participating in another concurrent intervention study

Locations

  • University of California San Francisco Benioff Children's Hospita; not yet accepting patients
    San Francisco, California, 94158, United States
  • Lucile Packard Children's Hospital not yet accepting patients
    Palo Alto, California, 94304, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati
ID
NCT03301311
Study Type
Interventional
Last Updated
October 4, 2017
I’m interested in this study!