Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease (NCT03301311) | Clinical Trial Compass
CompletedNot Applicable
Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
United States54 participantsStarted 2018-04-10
Plain-language 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.
Who can participate
Age range
7 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stool frequency
Timeframe: Daily through study completion (34 weeks from randomization)
2
Stool Consistency
Timeframe: Daily through study completion (34 weeks from randomization)
3
Pain Interference
Timeframe: Weekly through study completion (34 weeks from randomization)
4
Gastrointestinal Symptoms
Timeframe: Weekly through study completion (34 weeks from randomization)
5
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
Trial details
NCT IDNCT03301311
SponsorChildren's Hospital Medical Center, Cincinnati