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UC intervention diet for Ulcerative Colitis

N/A
Recruiting
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial will test whether a special diet can help treat ulcerative colitis by changing the microbiome.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in microbiome composition
Change in microbiome function
Secondary outcome measures
Decrease in clinical disease activity
Decrease in endoscopic disease activity

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ulcerative colitis patients with mild to moderate activityExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,166 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
2,152 Patients Enrolled for Ulcerative Colitis
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,588 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
1,419 Patients Enrolled for Ulcerative Colitis

Media Library

UC intervention diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04121806 — N/A
Ulcerative Colitis Research Study Groups: Ulcerative colitis patients with mild to moderate activity
Ulcerative Colitis Clinical Trial 2023: UC intervention diet Highlights & Side Effects. Trial Name: NCT04121806 — N/A
UC intervention diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04121806 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this study accepting participants?

"This clinical trial is seeking 20 participants, aged 18-75 years old, with a prior history of colitis ulcerosa. In addition to meeting the age requirement, applicants must have had at least 10cm involvement in their medical past and an active UC Mayo score of 2 or more within two months before enrolment. Furthermore, any applicable treatments should remain unchanged for four weeks preceding the study's start date and throughout its duration."

Answered by AI

Are there still vacancies available to partake in this clinical trial?

"According to clinicaltrials.gov, this trial is still open for recruitment and was first uploaded on March 1st 2021 with the latest update being September 12th 2022."

Answered by AI

Does this experiment allow for the participation of elderly persons?

"This experiment calls for participants aged between 18 and 75; whereas there are 65 trials available to those below the age of majority, 341 studies focus on seniors."

Answered by AI

How many individuals are participating in this trial?

"Affirmative. Per the information provided on clinicaltrials.gov, this research project is actively searching for volunteers to participate in their study which was first posted on March 1st 2021 and last amended September 12th 2022. 20 people are needed at a single medical site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Mount Sinai Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Apr 2025