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Dietary Supplement

Low Protein and High Fiber Diet for Ulcerative Colitis

N/A

Waitlist Available

Led By Laura Raffals, MD

Research Sponsored by Mayo Clinic

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 8 weeks

Awards & highlights

Study Summary

This trial will look at the effects of three diets on inflammation in the colon.

Eligible Conditions

Ulcerative Colitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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

Clinical remission derived from patient reported outcomes

Decrease in endoscopic Mayo score for ulcerative colitis inflammation

Secondary outcome measures

Intestinal inflammation determined from blood and stool samples

Urinary excretion of lactulose and 13C-Mannitol

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low Protein and High Fiber GroupExperimental Treatment1 Intervention

Subjects will consume a low protein and high fiber diet for 8 weeks

Group II: High Protein and Low Fiber GroupExperimental Treatment1 Intervention

Subjects will consume a high protein and low fiber diet for 8 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High Protein and Low Fiber Diet

2021

N/A

~10

Low Protein and High Fiber Diet

2021

N/A

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,778 Total Patients Enrolled

11 Trials studying Ulcerative Colitis

508 Patients Enrolled for Ulcerative Colitis

Laura Raffals, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

63 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

50 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

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

What is the total number of individuals participating in this research?

"Affirmative. The information posted on clinicaltrials.gov verifies that this medical trial is actively seeking volunteers, which was initially listed in August 2021 and lastly revised in August 2022. 70 participants need to be recruited from 2 different research centres."

Answered by AI

Is this experiment currently recruiting participants?

"As per clinicaltrials.gov, this medical experiment is currently welcoming enrollees with the initial posting on August 3rd 2021 and most recently edited on August 15th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

UC Cohort - The Influence of Diet on Gut Microbiotas

Laura E. Raffals, M.D 2021. "UC Cohort - The Influence of Diet on Gut Microbiotas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04933162.