Diet Intervention Treatment for Active Ulcerative Colitis

Mount Sinai Hospital, Canada

Status: Enrolling

Conditions: Colitis, Ulcerative

Treatments: Other: UC intervention diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04121806

19-0112-A

3U01DK062423-18S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.

Full description

The etiology of inflammatory bowel disease (IBD), including ulcerative colitis (UC), is complex and poorly understood, but the current hypothesis is that IBD arises from an aberrant immune response to commensal bacteria in a genetically susceptible host, and is triggered by environmental factors. Environmental factors such as the microbiome and diet, play a significant role in the risk of IBD. Diet has been identified as one of the main drivers of the microbiome composition and the microbiome and diet can work in tandem to affect host physiology.

In spite of patient interest in diet and numerous diet studies, currently there is no diet that is clinically validated or universally agreed upon for adult IBD patients. We also lack rigorous studies to show how the microbiome is influenced by diet and affects patient outcomes.

We propose to use a sustainable non-elemental diet aimed at altering the microbiome in patients with mild to moderately active UC to alter their disease activity.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Females and Males between the ages of 18 - 75 years of age at the time of enrolment

  • Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria
  • Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment
  • Must have had > 10cm involvement at some point in their disease history
  • FCP>250 or active endo within 6 months
  • If a smoker, must not change smoking habits (frequency) during the course of the study
  • If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study

Exclusion criteria

• • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment

  • Pregnant or lactating females
  • Allergy or intolerance to key or a great number food components of the study diet
  • Current NSAID use
  • Diagnosed with PSC
  • Using topical therapies or suppositories
  • Antibiotic use within 4 weeks of the study enrollment or during the study
  • Confirmed C. difficile infection within 3 months of recruitment;
  • Diagnosis of primary PSC;
  • Currently using topical therapies or suppositories
  • History of dysplasia or colorectal neoplasia.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ulcerative colitis patients with mild to moderate activity

Experimental group

Description:

Participants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet.

Treatment:

Other: UC intervention diet