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Fasting Mimicking Diet for Ulcerative Colitis

N/A
Recruiting
Led By Sidhartha R 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
Age of 18-70 at start of study (inclusive)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparison of sibdq score up to 14 days before starting cycle 1, and within 6 days after completing cycle 3. 1 cycle of ircd lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.
Awards & highlights

Study Summary

This trial is testing whether a fasting mimicking diet can help with Ulcerative Colitis by reducing inflammation.

Who is the study for?
Adults aged 18-70 with mild to moderate Ulcerative Colitis can join this study. They must not be underweight, pregnant, or nursing and should have no history of significant heart disease, liver or kidney disorders, severe illness, recent weakening medical procedures, or specific dietary restrictions including nut allergies.Check my eligibility
What is being tested?
The trial is testing a Fasting Mimicking Diet (FMD) against a regular diet in people with Ulcerative Colitis. Participants will undergo three cycles of a five-day FMD to see if it reduces inflammation and improves quality of life compared to those on their usual diet.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to dietary changes. Since the diet mimics fasting while allowing food intake, there might also be temporary feelings of hunger or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~comparison of crp levels up to 14 days before starting cycle 1, and within 6 days after completing cycle 3. 1 cycle of ircd lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.
This trial's timeline: 3 weeks for screening, Varies for treatment, and comparison of crp levels up to 14 days before starting cycle 1, and within 6 days after completing cycle 3. 1 cycle of ircd lasts 5 days and is administered once a month, followed by regular diet for the rest of the month. 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 response as per partial Mayo score
Secondary outcome measures
Change in C-Reactive Protein (CRP).
Change in Erythrocyte Sedimentation Rate (ESR).
Change in Fecal Calprotectin.
+7 more
Other outcome measures
Assessment of primary and key secondary endpoints at baseline versus 3 months after the start of Cycle 3.
Changes in cytokines/chemokines and immune cell profiles using flow cytometry and mass cytometry (CyTOF).
Changes in gut metabolites (including short-chain fatty acid and bile acid profiles) and microbiome profiles (using 16S rRNA/shotgun metagenomics).
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fasting Mimicking DietExperimental Treatment1 Intervention
Three cycles of a 5-day reduced calorie diet
Group II: Regular Diet Control ArmPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,280 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
187 Patients Enrolled for Ulcerative Colitis
Sidhartha R Sinha, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

Fasting Mimicking Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03615690 — N/A
Ulcerative Colitis Research Study Groups: Fasting Mimicking Diet, Regular Diet Control Arm
Ulcerative Colitis Clinical Trial 2023: Fasting Mimicking Diet Highlights & Side Effects. Trial Name: NCT03615690 — N/A
Fasting Mimicking Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03615690 — N/A

Frequently Asked Questions

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

What is the capacity of participants for this clinical trial?

"Affirmative. The information presented on clinicaltrials.gov suggests that this medical study is currently recruiting members; the initial posting date was December 15th 2020 and it has been updated as recently as April 21st 2022. 75 people are required to be recruited from a single location."

Answered by AI

Is there still availability for individuals to join this research project?

"Affirmative. According to clinicaltrials.gov, this medical exploration has opened recruitment since December 15th 2020 and was last updated on April 21st 2022. It proposes the enrolment of 75 individuals from a single site."

Answered by AI

Could I become a participant in this trial?

"This clinical trial is seeking 75 participants who have altered their diets and are aged between 18-70."

Answered by AI

Does this clinical trial include geriatric individuals as participants?

"This scientific research is accepting participants of legal adulthood and under 70 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Influence of a Fasting Mimicking Diet on Ulcerative Colitis
Sidhartha Ranjit Sinha 2020. "The Influence of a Fasting Mimicking Diet on Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03615690.
All > Inflammatory Bowel Disease > Diet
~11 spots leftby Dec 2024
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