Microbiota-targeted Diet for Pediatric UC

Children's Hospital of Philadelphia5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical Remission

Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)

Time frame: At 6 weeks following enrollment

Secondary Outcomes

Dietary Compliance

Using modified Medication Adherence Rating Scale (MARS) questionnaire

Time frame: Up to 12 weeks following enrollment

Change in C-reactive protein (CRP) between baseline and week 12

Time frame: 12 weeks

Change in erythrocyte sedimentation rate (ESR) between baseline and week 12

Time frame: 12 weeks

Change in fecal calprotectin (FCP) between baseline and week 12

Time frame: 12 weeks

Microbial composition of the gastrointestinal tract

Change in the microbial composition of the stool and rectum from baseline to 12 weeks.

Time frame: 12 weeks

Microbiota-targeted Diet for Pediatric UC

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes