What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as enteral nutrition and the specific carbohydrate diet, have known side effects. Enteral nutrition can cause nausea, diarrhea, and abdominal discomfort. The specific carbohydrate diet may lead to nutritional deficiencies and gastrointestinal symptoms like bloating and gas, especially during the initial phase. Both treatments require careful monitoring to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Crohn's Disease that focus on reducing inflammation and modulating the immune response. These include biologics like infliximab (Remicade), adalimumab (Humira), and ustekinumab (Stelara), which target specific components of the immune system to reduce inflammation. While these drugs are not dietary therapies, they share the goal of reducing inflammation to manage Crohn's Disease. Enteral nutrition and the specific carbohydrate diet are non-pharmacological approaches that aim to achieve similar outcomes by altering the gut environment and reducing inflammatory triggers.

What other types of research exist?

Promising novel alternatives to dietary therapy for Crohn's Disease patients include: 1) Probiotics, which have shown improvement in inflammation and symptoms in small studies; 2) Fecal Microbiota Transplantation (FMT), associated with endoscopic remission in observational studies; 3) Anti-inflammatory agents like Infliximab, used for refractory cases; 4) Advanced imaging techniques such as Multispectral Optoacoustic Tomography for noninvasive assessment of disease activity. These alternatives offer potential benefits and should be discussed with a healthcare provider.

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Dietary Therapy for Crohn's Disease and Ulcerative Colitis

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6 and week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two special diets to help people with active Crohn's Disease or Ulcerative Colitis. One diet is a liquid nutrient formula, and the other limits certain carbs. The goal is to see if these diets can improve gut health and reduce symptoms.

Who is the study for?

Adults with active Crohn's Disease or Ulcerative Colitis confirmed by recent colonoscopy can join. They must have a certain level of disease activity and be on stable IBD medication, except for decreasing steroids. Excluded are those with stomas, J pouches, recent bowel surgery, chronic narcotic use for pain, recent antibiotic or enteral diet use, pregnancy/breastfeeding women, celiac disease sufferers.

What is being tested?

The trial is testing two diets: an elemental diet (enteral nutrition) and the specific carbohydrate diet to see how they affect gut health in Crohn's Disease and Ulcerative Colitis patients over a 6-week period at Massachusetts General Hospital. Participants choose their preferred diet and follow it strictly before returning to normal eating.

What are the potential side effects?

Potential side effects may include changes in digestion like constipation or diarrhea due to dietary adjustments. There might also be nutritional deficiencies if the diets do not meet all vitamin and mineral needs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 and week 12 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 remission

Secondary study objectives

Biochemical response - CRP

Biochemical response - fecal calprotectin

Clinical response

Other study objectives

Change in gut microbiome

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Elemental diet armActive Control1 Intervention

The partial elemental diet will be sufficient to provide 50% of the daily caloric needs for each patient with the remainder from a standard low-residue diet

Group II: Specific carbohydrate armActive Control1 Intervention

The specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient.

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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, such as enteral nutrition and the specific carbohydrate diet, work by reducing inflammation and promoting gut healing. Enteral nutrition provides a nutritionally complete liquid diet that minimizes the digestive workload and inflammation. The specific carbohydrate diet eliminates complex carbohydrates to alter the gut microbiome and reduce inflammation by limiting the growth of harmful bacteria. These dietary approaches are important for Crohn's Disease patients as they offer non-pharmacological options to manage symptoms and potentially reduce reliance on medications with more severe side effects.

Dietary Management of Pediatric Inflammatory Bowel Disease.