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Intermittent Fasting for Crohn's Disease

N/A

Waitlist Available

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

Mild to moderate Crohn's disease (CDAI score 151-450)

Between the ages of 18-70 (inclusive)

Must not have

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

Women who are pregnant, nursing or expect to be pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline versus within 6 days after 3rd cycle of ircd. 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

No Placebo-Only Group

Summary

This trial is investigating whether an Intermittent Calorie Reduced Diet that mimics fasting could help treat Crohn's disease by reducing inflammation.

Who is the study for?

Adults aged 18-70 with mild to moderate Crohn's disease can join this trial. It's not for those allergic to nuts, severely weakened by illness or medical procedures, with severe heart issues, pregnant/nursing women, or anyone on a calorie-restricted diet. People who've had certain gastrointestinal surgeries or have serious conditions like diabetes at risk of hypoglycemia are also excluded.

What is being tested?

The study tests an Intermittent Reduced Calorie Diet (IRCD) that mimics fasting and is safe according to the FDA. The goal is to see if IRCD reduces inflammation and improves life quality in Crohn's disease patients over five-day periods.

What are the potential side effects?

Potential side effects may include nutritional deficiencies due to reduced calorie intake and possible reactions in individuals sensitive to specific dietary components within the IRCD meal plan.

Eligibility Criteria

Inclusion Criteria

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

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My Crohn's disease is in the mild to moderate stage.

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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 bad heart failure or a weak heart pump.

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I am not pregnant, nursing, or planning to become pregnant.

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I have diabetes and am on medication that could lower my blood sugar too much.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed within 6 days after 3rd cycle of ircd. 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 ~assessed within 6 days after 3rd cycle of ircd. 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 assessed within 6 days after 3rd cycle of ircd. 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.

Secondary study objectives

Change in C-reactive protein (CRP) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.

Change in Erythrocyte Sedimentation Rate (ESR) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.

Change in fecal calprotectin at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.

+4 more

Other study objectives

Changes in clinical markers of disease activity

Changes in cytokines/chemokines and immune cell profiles

Changes in gut metabolites (including short-chain fatty acid and bile acid profiles) and microbiome profiles (using 16S rRNA/shotgun metagenomics)

+3 more