Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

Completed · Not applicable

Conditions studied: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Indeterminate Colitis

In brief

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 four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.

Key facts

Study ID

NCT03301311

Run by

Children's Hospital Medical Center, Cincinnati

People needed

54

Starts

2018-04-10

Expected to finish

2020-09-08

Last updated by the study team

2022-06-28

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• Complex and Unstable IBD:
• Currently or within the past 9 months has had an 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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Lucile Packard Children's Hospital — Palo Alto, California, United States
• University of California San Francisco Benioff Children's Hospita; — San Francisco, California, United States
• Nemours, Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Nemours Children's Speciality Care — Jacksonville, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• GI Care for Kids — Atlanta, Georgia, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Levine Children's Hospital — Charlotte, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Dell Children's Medical Center of Central Texas — Austin, Texas, United States
• UT Soutwestern Medical Center — Dallas, Texas, United States
• Pediatric Specialists of Virginia — Fairfax, Virginia, United States
• Children's Hospital of the King's Daughters — Norfolk, Virginia, United States
• Seattle Children's — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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