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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Indeterminate Colitis; Crohn Disease

Treatments: Other: Modified Specific Carbohydrate Diet (MSCD); Other: Specific Carbohydrate Diet (SCD)

Study type: Interventional

Funder types: Other

Identifiers

NCT03301311

CIN001-PRODUCE

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Specific Carbohydrate Diet (First)

Experimental group

Description:

Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey.

Treatment:

Other: Specific Carbohydrate Diet (SCD)

Other: Modified Specific Carbohydrate Diet (MSCD)

Modified Specific Carbohydrate Diet (First)

Experimental group

Description:

Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted.

Treatment:

Other: Specific Carbohydrate Diet (SCD)

Other: Modified Specific Carbohydrate Diet (MSCD)