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Fermented Foods Diet for Ulcerative Colitis

N/A

Recruiting

Led By Sidhartha Sinha, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of UC

Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (data collection 1) versus week 10 (data collection 2).

Awards & highlights

Study Summary

This trial will test if a diet rich in fermented foods can help improve symptoms and quality of life in people with UC.

Who is the study for?

This trial is for men and women over 18 with mild to moderate Ulcerative Colitis (UC), confirmed by diagnosis. Participants must have symptoms, shown by a partial Mayo Score of 2-7, and elevated fecal calprotectin levels. They need to give written consent to join.Check my eligibility

What is being tested?

The study aims to understand the impact of a diet supplemented with fermented foods on inflammation and life quality in UC patients compared to those on a regular diet. It explores how these foods might affect gut health and inflammatory responses.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include changes in digestion or discomfort due to dietary adjustments. Fermented foods can sometimes cause bloating or gas as the body adapts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ulcerative colitis.

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My symptoms are moderate, based on a specific score.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (data collection 1) versus week 10 (data collection 2).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (data collection 1) versus week 10 (data collection 2).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (data collection 1) versus week 10 (data collection 2). 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 the clinical disease activity inflammatory marker fecal calprotectin

Secondary outcome measures

Changes in cytokines/chemokines and immune cell profiles

Changes in gut microbiome profiles

Clinical remission as per partial Mayo score.

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fermented Food-Supplemented DietExperimental Treatment1 Intervention

Patients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks.

Group II: Regular Diet Control ArmPlacebo Group1 Intervention

Patients in this arm will continue their regular diet throughout the 10 weeks of study with a maximum of 1 serving of fermented foods per day.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,171 Total Patients Enrolled

9 Trials studying Ulcerative Colitis

241 Patients Enrolled for Ulcerative Colitis

Sidhartha Sinha, MDPrincipal InvestigatorStanford University

4 Previous Clinical Trials

184 Total Patients Enrolled

1 Trials studying Ulcerative Colitis

15 Patients Enrolled for Ulcerative Colitis

Media Library

Fermented Food-supplemented Diet Clinical Trial Eligibility Overview. Trial Name: NCT04401605 — N/A

Ulcerative Colitis Research Study Groups: Fermented Food-Supplemented Diet, Regular Diet Control Arm

Ulcerative Colitis Clinical Trial 2023: Fermented Food-supplemented Diet Highlights & Side Effects. Trial Name: NCT04401605 — N/A

Fermented Food-supplemented Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04401605 — N/A

Frequently Asked Questions

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

How many individuals are eligible to participate in this clinical trial?

"That is correct. Clinicaltrials.gov contains information that this experiment, which debuted on September 14th 2020, is currently recruiting patients. A total of 21 people must be enlisted from a single site."

Answered by AI

Is the research project actively seeking participants?

"Affirmative. Per the clinicaltrials.gov records, this clinical trial remains open to participants and was initially posted on September 14th 2020. To date, there have been 21 patients recruited from a single location with an update made on May 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fermented Food-Supplemented Diet in Ulcerative Colitis

Sidhartha Ranjit Sinha 2020. "Fermented Food-Supplemented Diet in Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04401605.

All > Inflammatory Bowel Disease > Colitis