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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
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.
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Stool frequency
Self-reported number of stools per day entered as an integer in the study mobile app
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and once at the end of each treatment period (weeks 10, 18, 26 and 34) for a total of 5 times
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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
...and 10 more locations
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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)
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.
Time frame: Weekly through study completion (34 weeks from randomization)
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).
Time frame: Weekly through study completion (34 weeks from randomization)