Summary

for people ages 7-18 (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 7-18 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 DiseasesCrohn DiseaseUlcerative ColitisIndeterminate ColitisColitisUlcerColitis, UlcerativeSpecific Carbohydrate Diet (SCD)Modified Specific Carbohydrate Diet (MSCD)Specific Carbohydrate Diet (First)Modified Specific Carbohydrate Diet (First)

Eligibility

You can join if…

Open to people ages 7-18

  • Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis (IC)
  • Age 7-18 years
  • Enrolled in the ImproveCareNow (ICN2) registry
  • Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment.
  • Potential participants who are close to meeting one of the acute inflammation and/or elevated acute phase reactant markers and who meet all other study criteria will be considered for study participation on a case by case basis by the investigative study team in consultation with the patient's primary gastroenterologist.

You CAN'T join if...

Complex and Unstable IBD:

  • Currently or within the past 9 months has had an intra-abdominal abscess, fistula, stricturing CD, or ostomy
  • Severe disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of >45 or Pediatric Ulcerative Colitis Activity Index (PUCAI) score of >60 assessed within three weeks of enrollment
  • Ever had history of full colectomy
  • Hospitalization or surgery planned within 3 months
  • Ongoing active gastrointestinal infection
  • Severe Malnutrition (BMI less than 5th 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
  • If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of enrollment but they are noncompliant per the determination of the patient's dietitian/primary gastroenterologist, then this patient is eligible to participant in the study.
  • 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;accepting new patients
    San FranciscoCalifornia94158United States
  • Lucile Packard Children's Hospitalaccepting new patients
    Palo AltoCalifornia94304United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati
ID
NCT03301311
Study Type
Interventional
Last Updated