Ulcerative Colitis
Conditions
Brief summary
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.
Interventions
OTHERUlcerative Colitis Diet (UCD)
The primary study intervention is a novel dietary intervention, the UC Diet. The UC Diet is a structured 12-week diet with a step down phase designed to remove products that allow harmful bacteria to thrive and add products that can change the bacteria in the gut to induce remission
Sponsors
Wolfson Medical Center
IWK Health Centre
National Institutes of Health (NIH)
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Established diagnosis of UC * Age: 8-19 (inclusive) * Mild to moderate active disease, 10\<PUCAI\<45 * Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks. * Participant has agreed to follow the UCD for 12 weeks
Exclusion criteria
* Any proven current infection such as positive stool culture, parasite or C. difficile within the past 4 weeks * Antibiotic or corticosteroid use in the past 2 weeks * Use of biologics in present or in the past * PUCAI\>45 * Acute severe UC in the previous 12 months * Current extra intestinal manifestation of UC * Primary Sclerosing Cholangitis (PSC) or liver disease * Pregnancy * Known food allergy to mandatory foods in the UCD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | At 6 weeks following enrollment | Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Compliance | Up to 12 weeks following enrollment | Using modified Medication Adherence Rating Scale (MARS) questionnaire |
| Change in C-reactive protein (CRP) between baseline and week 12 | 12 weeks | — |
| Change in erythrocyte sedimentation rate (ESR) between baseline and week 12 | 12 weeks | — |
| Change in fecal calprotectin (FCP) between baseline and week 12 | 12 weeks | — |
| Microbial composition of the gastrointestinal tract | 12 weeks | Change in the microbial composition of the stool and rectum from baseline to 12 weeks. |
Countries
United States
Outcome results
None listed