Clinical trial NCT03301311: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Indeterminate Colitis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Seattle Children's Hospital
name: Dayton Children's Hospital
name: Brown University
First posted: 2017-10-04
Enrollment: 54
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stool frequency
timeFrame: Daily through study completion (34 weeks from randomization)
measure: Stool Consistency
timeFrame: Daily through study completion (34 weeks from randomization)
measure: Pain Interference
timeFrame: Weekly through study completion (34 weeks from randomization)
measure: Gastrointestinal Symptoms
timeFrame: Weekly through study completion (34 weeks from randomization)
measure: Fecal Calprotectin
timeFrame: 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:
measure: Provider measured disease activity
timeFrame: 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)
measure: Laboratory markers of disease activity and inflammation
timeFrame: 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)
measure: Growth
timeFrame: 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)
measure: Short Crohn's Disease Activity Index (sCDAI)
timeFrame: Weekly through study completion (34 weeks from randomization)
measure: Pediatric Ulcerative Colitis Activity Index (PUCAI)
timeFrame: Weekly through study completion (34 weeks from randomization)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Benioff Children's Hospita;
state: California
city: Wilmington
country: United States
facility: Nemours, Alfred I duPont Hospital for Children
state: Delaware
city: Jacksonville
country: United States
facility: Nemours Children's Speciality Care
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: GI Care for Kids
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Dallas
country: United States
facility: UT Soutwestern Medical Center
state: Texas
city: Fairfax
country: United States
facility: Pediatric Specialists of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Heather C Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lisa Opipari-Arrigan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.