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OpenTrials
Completed

NCT Number: NCT02922881

Microbiota-targeted Diet for Pediatric UC

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

8 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulcerative Colitis Diet (UCD)

Other

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 outcomes

  1. Clinical Remission

    Time frame: At 6 weeks following enrollment

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • IWK Health Centre
  • National Institutes of Health (NIH)
  • Wolfson Medical Center

Registry information

Official study 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

Acronym: UCD

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 4, 2016
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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