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

Ulcerative Colitis Clinical Trial

— PRODUCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301311
• Other study ID #: CIN001-PRODUCE
• Status: Completed
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: September 8, 2020

Study information

• Verified date: June 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 8, 2020
• Est. primary completion date: September 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Specific Carbohydrate Diet (SCD)
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 (MSCD)
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.

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Brown University, Dayton Children's Hospital, Seattle Children's Hospital, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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, L — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Provider measured disease activity	Pediatric Ulcerative Colitis Index (PUCAI) or Short Pediatric Crohn's Index (sPCDAI) are completed by care providers at all scheduled clinic visits as part of standard of care and are entered into the ImproveCareNow (ICN) registry.	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)
Secondary	Laboratory markers of disease activity and inflammation	C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), albumin, and hematocrit as collected as part of standard of care and are entered into the ImproveCareNow (ICN) registry.	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)
Secondary	Growth	Weight and height are collected at all clinic visits and at the dietitian study follow up visits (2 weeks into the first diet period of each diet). These data are entered into the ICN registry as part of regular data entry. We will calculate weight for age Z-scores for all entries during study period. The age-specific mean and standard deviation from U.S. population norms will be used to calculate Z-scores using the Centers for Disease Control Epi-Info program.	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)
Secondary	Short Crohn's Disease Activity Index (sCDAI)	The short Crohn's disease activity index (sCDAI) will be used to assess disease activity based on self-report via the study app. For the sCDAI, items assess general well-being, abdominal pain, and liquid stools. Respondents are asked to report on symptoms for the previous 24 hour period. Scores are calculated based on a published algorithm.	Weekly through study completion (34 weeks from randomization)
Secondary	Pediatric Ulcerative Colitis Activity Index (PUCAI)	A self-reported version of the Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to assess disease activity based on self-report via the study app. For the PUCAI, respondents are asked to report on abdominal pain, bloody stools, stool consistency, stool frequency, nocturnal stools, and activity level over the prior 24-hours. A weighted, summed score is calculated with higher scores indicating worse disease (score range 0-85).	Weekly through study completion (34 weeks from randomization)