Clinical Trial: Microbiota-targeted Diet for Pediatric UC

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Clinical Remission [ Time Frame: At 6 weeks following enrollment ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Dietary Compliance [ Time Frame: Up to 12 weeks following enrollment ]
    Using modified Medication Adherence Rating Scale (MARS) questionnaire
  • Change in C-reactive protein (CRP) between baseline and week 12 [ Time Frame: 12 weeks ]
  • Change in erythrocyte sedimentation rate (ESR) between baseline and week 12 [ Time Frame: 12 weeks ]
  • Change in fecal calprotectin (FCP) between baseline and week 12 [ Time Frame: 12 weeks ]
  • Microbial composition of the gastrointestinal tract [ Time Frame: 12 weeks ]
    Change in the microbial composition of the stool and rectum from baseline to 12 weeks.


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: June 13, 2016
Date Started: January 2017
Date Completion: July 2019
Last Updated: January 6, 2017
Last Verified: January 2017