Diet Intervention Treatment for Active Ulcerative Colitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04121806
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mount Sinai Hospital, Canada
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Additional Details

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.

Arms & Interventions

Arms

Experimental: Ulcerative colitis patients with mild to moderate activity

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.

Interventions

Other: - UC intervention diet

The treatment diet has been designed based on the literature with the goal of influencing the biodiversity and density of the microbiome. All food through the duration of the 8 week dietary intervention period of the study will be provided to the treatment arm study participants.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Mount Sinai Hospital, Toronto, Ontario, Canada

Status

Recruiting

Address

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5