Clinical trial NCT04121806: Diet Intervention Treatment for Active Ulcerative Colitis
Official title: Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colitis, Ulcerative
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in microbiome composition
timeFrame: 10 weeks
measure: Change in microbiome function
timeFrame: 10 weeks
Secondary outcomes:
measure: Decrease in endoscopic disease activity
timeFrame: 10 weeks
measure: Decrease in clinical disease activity
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: