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Completed

NCT Number: NCT03301311

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Indeterminate Colitis Intestinal Diseases Ulcerative Colitis

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 (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.

Primary outcomes

  1. Stool frequency

    Time frame: Daily through study completion (34 weeks from randomization)

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

  2. Stool Consistency

    Time frame: Daily through study completion (34 weeks from randomization)

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

  3. Pain Interference

    Time frame: Weekly through study completion (34 weeks from randomization)

    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.

  4. Gastrointestinal Symptoms

    Time frame: Weekly through study completion (34 weeks from randomization)

    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.

  5. Fecal Calprotectin

    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

    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.

Secondary outcomes

  1. Provider measured disease activity

    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)

    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.

  2. Laboratory markers of disease activity and inflammation

    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)

    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.

  3. Growth

    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)

    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.

  4. Short Crohn's Disease Activity Index (sCDAI)

    Time frame: Weekly through study completion (34 weeks from randomization)

    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.

  5. Pediatric Ulcerative Colitis Activity Index (PUCAI)

    Time frame: Weekly through study completion (34 weeks from randomization)

    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).

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Brown University
  • Dayton Children's Hospital
  • Seattle Children's Hospital
  • University of California, San Francisco

Registry information

Official study 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

Acronym: PRODUCE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2017
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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