What side effects are associated with this type of intervention?

Common side effects of a low-fat, high-fiber diet for Crohn's Disease include bloating, gas, and abdominal discomfort, particularly if fiber is introduced too quickly. To minimize these effects, it is recommended to start with a low dose of fiber and gradually increase. Reducing fat intake generally has fewer direct gastrointestinal side effects but requires careful planning to ensure adequate intake of essential fatty acids and fat-soluble vitamins.

What prior FDA approvals exist?

FDA-approved treatments for Crohn's Disease primarily include medications such as aminosalicylates, corticosteroids, immunomodulators, and biologics like anti-TNF agents (e.g., infliximab, adalimumab). These treatments aim to reduce inflammation and manage symptoms. While dietary interventions like a low-fat, high-fiber diet are being studied for their potential benefits in improving gut health and reducing inflammation, they are not yet FDA-approved treatments. Instead, they are considered complementary approaches to traditional medical therapies.

What other types of research exist?

Promising alternatives to a low-fat, high-fiber diet for Crohn's Disease patients include: 1) Wheat bran-inclusive diet, which has been shown to improve health-related quality of life and gastrointestinal function without adverse effects. 2) Low-FODMAP diet, which can reduce functional gastrointestinal symptoms in patients with inflammatory bowel disease. 3) Specific Carbohydrate Diet (SCD), which excludes refined sugars, dairy products, and complex carbohydrates, and has been associated with improvements in disease activity and inflammatory markers. 4) Partial enteral nutrition with a specific exclusion diet (CDED), which has shown better evidence for inducing remission. 5) Reduction of dietary poorly absorbed short-chain carbohydrates (FODMAPs), which improves abdominal symptoms. These alternatives should be considered in consultation with a healthcare provider to ensure they meet individual nutritional needs and health goals.

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Low-Fat High-Fiber Diet for Crohn's Disease

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

Common treatments for Crohn's Disease include dietary interventions, medications, and sometimes surgery. A low-fat, high-fiber diet aims to reduce inflammation and improve gut health by minimizing fat intake, which can exacerbate inflammation, and increasing fiber intake, which promotes healthy gut bacteria and bowel movements. This dietary approach can help manage symptoms and improve quality of life. Medications such as anti-inflammatory drugs, immunosuppressants, and biologics work by reducing inflammation and modulating the immune system to prevent flare-ups. These treatments are essential for Crohn's Disease patients as they help control symptoms, maintain remission, and prevent complications.

N/A

Waitlist Available

Led By Maria T Abreu, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosed of Crohn's Disease

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 36

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a low-fat, high-fiber diet to help people with stomach problems and inflammation feel better.

Who is the study for?

This trial is for adults aged 18-70 with Crohn's Disease who have mild to moderate symptoms (sCDAI <400). They must not have used antibiotics or probiotics within the last two weeks and should be on stable doses of certain medications. Participants need to live with someone involved in their daily diet and can only be on low doses of steroids.

What is being tested?

The study tests a low-fat, high-fiber diet (LFD) designed to reduce gastrointestinal symptoms and inflammation in Crohn's patients. It includes Dyadic Psychological Support (DPS) and Diet Counseling to help participants adhere to the dietary changes.

What are the potential side effects?

While specific side effects are not listed for this dietary intervention, some individuals may experience changes in digestion or bowel habits as they adjust to the new diet.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with Crohn's Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in fat intake

Rate of adherence to fat intake

Secondary study objectives

Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).

Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)

Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Experimental CD Low Fat Diet (LFD) GroupExperimental Treatment1 Intervention

Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks.

Group II: Experimental CD LFD + DPS GroupExperimental Treatment2 Interventions

Participants and one family member that lives with them will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. In addition, the participant and their family member will receive 12 consecutive weeks of Dyadic Psychological Support (DPS).

Group III: Crohn's Disease (CD) Control GroupActive Control1 Intervention

Participants will receive only the one time standard of care in-clinic diet counseling at visit 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dyadic Psychological Support (DPS)

2019

N/A

~300

0 / 1Eligibility 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

Common treatments for Crohn's Disease include dietary interventions, medications, and sometimes surgery. A low-fat, high-fiber diet aims to reduce inflammation and improve gut health by minimizing fat intake, which can exacerbate inflammation, and increasing fiber intake, which promotes healthy gut bacteria and bowel movements. This dietary approach can help manage symptoms and improve quality of life. Medications such as anti-inflammatory drugs, immunosuppressants, and biologics work by reducing inflammation and modulating the immune system to prevent flare-ups. These treatments are essential for Crohn's Disease patients as they help control symptoms, maintain remission, and prevent complications.