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
| Type | Name | Description |
|---|---|---|
| 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 |
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.