Health TrialsbyHealthPanel

Diet Intervention Treatment for Active Ulcerative Colitis

ConditionColitis, Ulcerative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMount Sinai Hospital, Canada

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• 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

Trial design

Design model

Single group

Treatments tested in this trial

  • UC intervention diet

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Ulcerative colitis patients with mild to moderate activityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in microbiome composition

measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual

Time frame
10 weeks
2

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

Time frame
10 weeks

Secondary outcomes

1

Decrease in endoscopic disease activity

measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual

Time frame
10 weeks
2

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

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mount Sinai Hospital, Canada

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
Apply now