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Fermented Food-supplemented Diet for Ulcerative Colitis

Stanford University, Palo Alto, CA
Ulcerative Colitis+2 More ConditionsFermented Food-supplemented Diet - Other
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Ulcerative Colitis
  • Inflammatory Bowel Disease
  • Diet Modification

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Treatment Group 1
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Dupilumab
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TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).

Week 10
Clinical remission as per partial Mayo score.
Patient global assessment
Symptomatic remission as per Patient Reported Outcome (PRO2) score
Week 10
Change in the clinical disease activity inflammatory marker fecal calprotectin
Changes in cytokines/chemokines and immune cell profiles
Changes in gut microbiome profiles
Clinical response as per partial Mayo score.
Effect of Fermented Food-Supplemented Diet on patient quality of life

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Treatment Group 1
2
Dupilumab
2
TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)

Trial Design

2 Treatment Groups

Fermented Food-Supplemented Diet
1 of 2
Regular Diet Control Arm
1 of 2

Experimental Treatment

Non-Treatment Group

21 Total Participants · 2 Treatment Groups

Primary Treatment: Fermented Food-supplemented Diet · Has Placebo Group · N/A

Fermented Food-Supplemented Diet
Other
Experimental Group · 1 Intervention: Fermented Food-supplemented Diet · Intervention Types: Other
Regular Diet Control Arm
Other
PlaceboComparator Group · 1 Intervention: Regular Diet · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (data collection 1) versus week 10 (data collection 2).

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,222 Previous Clinical Trials
34,904,576 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
218 Patients Enrolled for Ulcerative Colitis
Sidhartha Sinha, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
123 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
15 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have agreed in writing to participate in the study.
You are at least 18 years old, regardless of your gender.
You have been diagnosed with ulcerative colitis.
There are higher than normal levels of a protein called calprotectin in your stool.
You are experiencing symptoms related to the disease, with a specific score range called the partial Mayo Score.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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