← Back to Search

Other

Intermittent Fasting for Crohn's Disease

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
Mild to moderate Crohn's disease (CDAI score 151-450)
Between the ages of 18-70 (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline versus within 6 days after 3rd cycle of ircd and 3 months after 3rd cycle. 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 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.Check my eligibility
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.See study design
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
Select...
My Crohn's disease is in the mild to moderate stage.
Select...
I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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 outcome measures
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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Three cycles of a 5-day Intermittent Reduced Calorie Diet
Group II: Control ArmActive Control1 Intervention
Regular Diet

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,379 Previous Clinical Trials
17,333,318 Total Patients Enrolled
Sidhartha R Sinha, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Intermittent Reduced Calorie Diet (IRCD) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04147585 — N/A
Crohn's Disease Research Study Groups: Intervention Arm, Control Arm
Crohn's Disease Clinical Trial 2023: Intermittent Reduced Calorie Diet (IRCD) Highlights & Side Effects. Trial Name: NCT04147585 — N/A
Intermittent Reduced Calorie Diet (IRCD) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04147585 — N/A

Frequently Asked Questions

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

What criteria must a person meet to be eligible for this clinical trial?

"Currently, 75 individuals aged 18 to 70 who have been diagnosed with ileocolitis are being recruited for this clinical trial. Eligibility is contingent on demonstrating mild to moderate Crohn's disease (CDAI score 151-450)."

Answered by AI

Does this inquiry accept individuals aged eighty-five and above?

"According to the official enrollment requirements, patients must be between 18 and 70 years old to qualify for this clinical trial."

Answered by AI

Is there presently an opportunity to join this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research project is still in recruitment mode since it was first published on December 18th 2019 and last modified on August 26th 2022. Currently the study requires 75 volunteers from a single site."

Answered by AI

How many participants are being recruited for this trial?

"Affirmative. According to clinicaltrials.gov, this trial which was initially posted on December 18th 2019 is currently recruiting participants. 75 individuals are needed from a single medical site."

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
~4 spots leftby Jul 2024