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

NCT03301311 | Completed DMC

• 1 other identifier: CIN001-PRODUCE
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 20

Brief 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Stool frequency

  Self-reported number of stools per day entered as an integer in the study mobile app

  Daily through study completion (34 weeks from randomization)

• Stool Consistency

  Self-reported assessment of stool consistency using the Bristol Stool Scale entered in the study mobile app

  Daily through study completion (34 weeks from randomization)

• Pain Interference

  Patient reported outcome of pain interference measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale on the study app. The scale includes 8 items and responses to each item are on a 0 (Never) to 4 (Almost Always) scale. Higher scores indicate greater pain interference. Look up tables provided by the PROMIS Assessment Center will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.

  Weekly through study completion (34 weeks from randomization)

• Gastrointestinal Symptoms

  Self-reported outcome of GI symptom burden measured using the PROMIS GI Symptoms scale on the study app. The scale includes 4 items and responses to each item are on a 1 (Never) to 5 (Almost Always) scale. Higher scores indicate greater GI symptom burden. Look up tables provided by the measure developers will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.

  Weekly through study completion (34 weeks from randomization)

• Fecal Calprotectin

  Laboratory measurement of intestinal inflammation. Stool will be collected by participants at home and will be mailed to a central lab for processing and analysis.

  At baseline and once at the end of each treatment period (weeks 10, 18, 26 and 34) for a total of 5 times

Secondary Outcomes (5)

• Provider measured disease activity

  At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)

• Laboratory markers of disease activity and inflammation

  At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)

• Growth

  At baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)

• Short Crohn's Disease Activity Index (sCDAI)

  Weekly through study completion (34 weeks from randomization)

• Pediatric Ulcerative Colitis Activity Index (PUCAI)

  Weekly through study completion (34 weeks from randomization)

Study Arms (2)

Specific Carbohydrate Diet (First)

EXPERIMENTAL

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.

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

Modified Specific Carbohydrate Diet (First)

EXPERIMENTAL

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.

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

Interventions

Specific Carbohydrate Diet (SCD) OTHER

Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.

Modified Specific Carbohydrate Diet (First); Specific Carbohydrate Diet (First)

Modified Specific Carbohydrate Diet (MSCD) OTHER

Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.

Modified Specific Carbohydrate Diet (First); Specific Carbohydrate Diet (First)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• University of California, San Francisco: collaborator
• Seattle Children's Hospital: collaborator
• Dayton Children's Hospital: collaborator
• Brown University: collaborator

Study Sites (20)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

University of California San Francisco Benioff Children's Hospita;

San Francisco, California, 94158, United States

Location

Nemours, Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Nemours Children's Speciality Care

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

GI Care for Kids

Atlanta, Georgia, 30342, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

UT Soutwestern Medical Center

Dallas, Texas, 75235, United States

Location

Pediatric Specialists of Virginia

Fairfax, Virginia, 22031, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Kaplan HC, Opipari-Arrigan L, Yang J, Schmid CH, Schuler CL, Saeed SA, Braly KL, Chang F, Murphy L, Dodds CM, Nuding M, Liu H, Pilley S, Stone J, Woodward G, Yokois N, Goyal A, Lee D, Yeh AM, Lee P, Gold BD, Molle-Rios Z, Zwiener RJ, Ali S, Chavannes M, Linville T, Patel A, Ayers T, Bassett M, Boyle B, Palomo P, Verstraete S, Dorsey J, Kaplan JL, Steiner SJ, Nguyen K, Burgis J, Suskind DL; ImproveCareNow Pediatric IBD Learning Health System. Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials. Am J Gastroenterol. 2022 Jun 1;117(6):902-917. doi: 10.14309/ajg.0000000000001800. Epub 2022 Apr 20.

  PMID: 35442220 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Heather C Kaplan, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Lisa Opipari-Arrigan, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We are using a series of N-of-1 trials where patients alternate (cross) between the two study interventions at set intervals. N-of-1 trial results will be examined at the individual and population level (through meta-analysis of individual N-of-1 trials)

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 4, 2017
• Study Start: April 10, 2018
• Primary Completion: September 8, 2020
• Study Completion: September 8, 2020
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Within a year after study completion.

Locations

US (20)