Microbiota-targeted Diet for Pediatric UC (UCD)

Use of a Novel Diet (UC Diet) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study

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 Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Ulcerative Colitis Diet (UCD)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulcerative Colitis Diet; Participants will receive a structured 12-week diet with a step down phase.	Other: Ulcerative 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Remission	Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)	At 6 weeks following enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Compliance	Using modified Medication Adherence Rating Scale (MARS) questionnaire	Up to 12 weeks following enrollment
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	Change in the microbial composition of the stool and rectum from baseline to 12 weeks.	12 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institutes of Health (NIH); Wolfson Medical Center; IWK Health Centre
• Investigators: Principal Investigator: Lindsey Albenberg, DO, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 16-013075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No