Intermittent Fasting for Crohn's Disease

TF
Overseen ByTouran Fardeen
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a diet that mimics fasting can reduce inflammation in people with mild to moderate Crohn's disease, a condition causing inflammation in the digestive tract. Participants will either follow this special diet, the Intermittent Reduced Calorie Diet (IRCD), for five days or maintain their regular eating habits. The researchers aim to determine if the fasting-like diet can improve inflammation markers and overall quality of life. Individuals with Crohn's who experience mild to moderate symptoms and are not on conflicting medications might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches to managing Crohn's disease symptoms.

Will I have to stop taking my current medications?

The trial does not clearly state if you need to stop your current medications, but it excludes people taking medications that can't be safely combined with a calorie-restricted diet. It's best to discuss your specific medications with the trial team.

What prior data suggests that this diet is safe for Crohn's disease patients?

Research has shown that diets similar to fasting, such as the Intermittent Reduced Calorie Diet (IRCD), might aid in managing conditions like Crohn's disease. In animal studies, these diets often improved bowel health without significant weight change. Early human research also suggests that these diets could help manage inflammatory bowel diseases, like Crohn's, by potentially reducing inflammation.

Regarding safety, the FDA generally considers the ingredients in these diets safe, which is reassuring. However, due to limited research on using diets for Crohn's disease, more studies are needed to fully understand their safety and effectiveness for people with Crohn's.

For those considering joining a clinical trial for this diet, current evidence suggests it is generally well-tolerated, but individual experiences can vary. Always consult a healthcare provider before changing your diet or treatment plan.12345

Why are researchers excited about this trial?

Researchers are excited about the Intermittent Reduced Calorie Diet (IRCD) for Crohn's disease because it offers a non-drug approach that could complement or even reduce the need for medications like corticosteroids or biologics. Unlike standard treatments, which often focus on suppressing the immune system, IRCD uses dietary modifications to potentially reduce inflammation naturally. This method might provide a more holistic way to manage symptoms with fewer side effects, making it an appealing option for long-term disease management.

What evidence suggests that this diet is effective for Crohn's disease?

Research suggests that an Intermittent Reduced Calorie Diet (IRCD), which participants in this trial may follow, might help lower inflammation in people with Crohn's Disease. Studies on other inflammatory conditions have shown that fasting or eating fewer calories can be effective. Some findings indicate that diets similar to fasting, like IRCD, can reduce gut inflammation and aid in healing. Early evidence from these diets has shown promise in improving symptoms and quality of life. Although more research is needed, these initial results offer encouragement for those with Crohn's Disease.12567

Who Is on the Research Team?

SR

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I do not have severe heart disease, such as bad heart failure or a weak heart pump.
I am severely weakened by a disease or medical procedure.
I am not pregnant, nursing, or planning to become pregnant.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three cycles of a 5-day Intermittent Reduced Calorie Diet (IRCD) administered once a month, followed by a regular diet for the rest of the month

3 months

Follow-up

Participants are monitored for changes in quality of life, clinical response, and inflammatory markers after the treatment phase

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Intermittent Reduced Calorie Diet (IRCD)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Effects of an Intermittent Reduced Calorie Diet on Crohn's ...This research investigates whether markers of inflammation decrease and/or quality of life increases after five-day periods of the IRCD, and may provide ...
Mo1729 EFFECTS OF AN INTERMITTENT REDUCED ...Based on initial evidence and data from other chronic inflammatory diseases showing some effectiveness of fasting and/or caloric restriction ...
A review of the role of intermittent fasting ...The results from animal studies suggest either moderate or no changes in weight but improvements in colitis with IF. These improvements may be ...
Fasting-mimicking diet holds promise for treating people ...Results showed that fasting-mimicking diet caused a reduction in intestinal inflammation and an increase in intestinal stem cells in part by ...
Therapeutic Implications of Diet in Inflammatory Bowel ...The LFD group experienced greater relief in gut symptoms, reduction in IBS-SSS but did not show any decreases in markers of inflammation [67]. The results of ...
Effects of Crohn's disease exclusion diet on remissionOur findings suggested that the use of CDED seemed to be effective for induction and maintenance of remission in children and adults with mild to moderate ...
Intermittent Caloric Restriction in Patients With Mild to ...The investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security