Diet Intervention Treatment for Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

Official title:

Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121806
• Other study ID #: 19-0112-A
• Secondary ID: 3U01DK062423-18S
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2022
• Source: Mount Sinai Hospital, Canada
• Contact: Jenny Lee
• Phone: 4165864800
• Email: jenny.lee[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbiome composition	measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual	10 weeks
Primary	Change in microbiome function	measured by shotgun sequencing and comparing difference in enriched functional pathways between pretreatment diet and the treatment diet within an individual	10 weeks
Secondary	Decrease in endoscopic disease activity	measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual	10 weeks
Secondary	Decrease in clinical disease activity	measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual	10 weeks