What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include medications like mesalamine, corticosteroids, and immunosuppressants. Mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Corticosteroids may lead to weight gain, osteoporosis, hypertension, and increased infection risk. Immunosuppressants can result in bone marrow suppression, liver toxicity, and increased susceptibility to infections. Dietary interventions like the Fasting Mimicking Diet, which aim to reduce inflammation, are generally considered safe but may cause temporary side effects such as fatigue, headache, and gastrointestinal discomfort during the fasting periods.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including mesalamine, corticosteroids, immunomodulators like azathioprine and 6-mercaptopurine, and biologics such as infliximab and vedolizumab. These treatments primarily focus on reducing inflammation and modulating the immune response. While the Fasting Mimicking Diet (FMD) aims to reduce inflammation through metabolic effects similar to fasting, there are no FDA-approved treatments specifically mimicking this mechanism. However, dietary interventions and their impact on inflammation in UC are an emerging area of research.

What other types of research exist?

Promising novel alternatives to the Fasting Mimicking Diet for Ulcerative Colitis patients include: 1) The Mediterranean Diet, which has anti-inflammatory properties and has been associated with improved gut health. 2) The Specific Carbohydrate Diet (SCD), which eliminates complex carbohydrates and has shown benefits in reducing symptoms and inflammation in UC patients. 3) Probiotic and prebiotic supplementation, which can help modulate gut microbiota and reduce inflammation. 4) The Anti-Inflammatory Diet (AID), which focuses on foods that reduce inflammation and has shown promise in managing UC symptoms.

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Fasting Mimicking Diet for Ulcerative Colitis

Q: What is the mechanism of action of this treatment?

The Fasting Mimicking Diet (FMD) aims to reduce inflammation by mimicking the metabolic effects of fasting, which decreases pro-inflammatory cytokines and promotes autophagy, helping to regenerate healthier cells. This is crucial for Ulcerative Colitis (UC) patients as it addresses the chronic inflammation that causes symptoms like abdominal pain and diarrhea. Other common treatments, such as anti-inflammatory drugs, immunosuppressants, and biologics, target specific immune pathways to reduce inflammation and maintain remission, thereby improving the quality of life for UC patients.

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

Must not have

Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40%)

Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.

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.

Summary

This trial is testing a special diet that mimics fasting in people with mild to moderate Ulcerative Colitis. The diet allows people to eat certain safe foods while getting the benefits of fasting. Researchers want to see if this diet can reduce inflammation and improve quality of life for these patients.

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.

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.

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

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart disease, such as heart failure worse than NYHA grade 1 or a left ventricular ejection fraction below 40%.

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I have not had major gut surgery affecting my digestion.

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I am currently pregnant, nursing, or planning to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ comparison of esr 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~comparison of esr 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 esr 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical response as per partial Mayo score

Secondary study objectives

Change in C-Reactive Protein (CRP).

Change in Erythrocyte Sedimentation Rate (ESR).

Change in Fecal Calprotectin.

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Other study objectives

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).

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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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Fasting Mimicking Diet (FMD) aims to reduce inflammation by mimicking the metabolic effects of fasting, which decreases pro-inflammatory cytokines and promotes autophagy, helping to regenerate healthier cells. This is crucial for Ulcerative Colitis (UC) patients as it addresses the chronic inflammation that causes symptoms like abdominal pain and diarrhea. Other common treatments, such as anti-inflammatory drugs, immunosuppressants, and biologics, target specific immune pathways to reduce inflammation and maintain remission, thereby improving the quality of life for UC patients.