Microbiota-targeted Diet for Pediatric UC

Ulcerative Colitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922881
• Other study ID #: 16-013075
• Status: Completed
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	IWK Health Centre, National Institutes of Health (NIH), Wolfson Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission	Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)	At 6 weeks following enrollment
Secondary	Dietary Compliance	Using modified Medication Adherence Rating Scale (MARS) questionnaire	Up to 12 weeks following enrollment
Secondary	Change in C-reactive protein (CRP) between baseline and week 12		12 weeks
Secondary	Change in erythrocyte sedimentation rate (ESR) between baseline and week 12		12 weeks
Secondary	Change in fecal calprotectin (FCP) between baseline and week 12		12 weeks
Secondary	Microbial composition of the gastrointestinal tract	Change in the microbial composition of the stool and rectum from baseline to 12 weeks.	12 weeks