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Microbiota-targeted Diet for Pediatric UC (UCD)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulcerative Colitis Diet (UCD)
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

8 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ulcerative Colitis Diet

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2016
Last Updated
December 21, 2021
Sponsor
Children's Hospital of Philadelphia
Collaborators
Wolfson Medical Center, IWK Health Centre, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02922881
Brief Title
Microbiota-targeted Diet for Pediatric UC
Acronym
UCD
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Wolfson Medical Center, IWK Health Centre, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulcerative Colitis Diet
Arm Type
Experimental
Arm Description
Participants will receive a structured 12-week diet with a step down phase.
Intervention Type
Other
Intervention Name(s)
Ulcerative Colitis Diet (UCD)
Intervention Description
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 Measure Information:
Title
Clinical Remission
Description
Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)
Time Frame
At 6 weeks following enrollment
Secondary Outcome Measure Information:
Title
Dietary Compliance
Description
Using modified Medication Adherence Rating Scale (MARS) questionnaire
Time Frame
Up to 12 weeks following enrollment
Title
Change in C-reactive protein (CRP) between baseline and week 12
Time Frame
12 weeks
Title
Change in erythrocyte sedimentation rate (ESR) between baseline and week 12
Time Frame
12 weeks
Title
Change in fecal calprotectin (FCP) between baseline and week 12
Time Frame
12 weeks
Title
Microbial composition of the gastrointestinal tract
Description
Change in the microbial composition of the stool and rectum from baseline to 12 weeks.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Albenberg, DO
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Microbiota-targeted Diet for Pediatric UC

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