Clinical Trials Directory

Trials / Completed

CompletedNCT02922881

Microbiota-targeted Diet for Pediatric UC

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
8 Years – 19 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
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

Timeline

Start date
2017-03-08
Primary completion
2021-09-30
Completion
2021-09-30
First posted
2016-10-04
Last updated
2021-12-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02922881. Inclusion in this directory is not an endorsement.