Microbiota-targeted Diet for Pediatric UC

Not Applicable

Completed

• Conditions: Ulcerative Colitis
• Interventions: Other: Ulcerative Colitis Diet (UCD)

• Registration Number: NCT02922881
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Study Start: 2017-03-08
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulcerative Colitis Diet	Ulcerative Colitis Diet (UCD)	Participants will receive a structured 12-week diet with a step down phase.

Primary Outcome Measures

Name	Time	Method
Clinical Remission	At 6 weeks following enrollment	Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)

Secondary Outcome Measures

Name	Time	Method
Change in C-reactive protein (CRP) between baseline and week 12	12 weeks
Change in fecal calprotectin (FCP) between baseline and week 12	12 weeks
Dietary Compliance	Up to 12 weeks following enrollment	Using modified Medication Adherence Rating Scale (MARS) questionnaire
Change in erythrocyte sedimentation rate (ESR) 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.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States