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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

Summary

This trial is testing whether a special diet can help treat Crohn's disease or ulcerative colitis.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical remission
Secondary outcome measures
Biochemical response - CRP
Biochemical response - fecal calprotectin
Clinical response
Other outcome measures
Change in gut microbiome

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.

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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,638 Total Patients Enrolled

Media Library

Elemental diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02412553 — N/A
Crohn's Disease Research Study Groups: Elemental diet arm, Specific carbohydrate arm
Crohn's Disease Clinical Trial 2023: Elemental diet Highlights & Side Effects. Trial Name: NCT02412553 — N/A
Elemental diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02412553 — N/A
~7 spots leftby Oct 2026