Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microbiota-targeted Diet for Pediatric UC (UCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922881
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
Wolfson Medical Center
IWK Health Centre
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Ulcerative Colitis Diet (UCD) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Clinical Remission [ Time Frame: At 6 weeks following enrollment ]
    Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)


Secondary Outcome Measures :
  1. Dietary Compliance [ Time Frame: Up to 12 weeks following enrollment ]
    Using modified Medication Adherence Rating Scale (MARS) questionnaire

  2. Change in C-reactive protein (CRP) between baseline and week 12 [ Time Frame: 12 weeks ]
  3. Change in erythrocyte sedimentation rate (ESR) between baseline and week 12 [ Time Frame: 12 weeks ]
  4. Change in fecal calprotectin (FCP) between baseline and week 12 [ Time Frame: 12 weeks ]
  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922881


Contacts
Layout table for location contacts
Contact: Naomi Pressman 267-426-8413 Pressmann@email.chop.edu

Locations
Layout table for location information
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lindsay M Besecker    267-426-8414    ibdresearch@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Wolfson Medical Center
IWK Health Centre
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Lindsey Albenberg, DO Children's Hospital of Philadelphia
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02922881    
Other Study ID Numbers: 16-013075
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases