Microbiota-targeted Diet for Pediatric UC

NCT02922881 | Completed

• 1 other identifier: 16-013075
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Remission

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

  At 6 weeks following enrollment

Secondary Outcomes (5)

• Dietary Compliance

  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

  12 weeks

Study Arms (1)

Ulcerative Colitis Diet

EXPERIMENTAL

Participants will receive a structured 12-week diet with a step down phase.

Other: Ulcerative Colitis Diet (UCD)

Interventions

Ulcerative Colitis Diet (UCD) OTHER

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

Ulcerative Colitis Diet

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Wolfson Medical Center: collaborator
• IWK Health Centre: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Lindsey Albenberg, DO

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: October 4, 2016
• Study Start: March 8, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)