Dietary Therapy for Crohn's Disease and Ulcerative Colitis

Overseen By Ashwin N Ananthakrishnan, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Narcotics, Antibiotics

Disqualifiers: Pregnancy, Celiac disease, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effects of dietary changes on people with Crohn's disease (CD) or ulcerative colitis (UC), conditions that cause inflammation in the digestive tract. Participants will follow either an elemental diet, which involves consuming a special liquid formula for part of their nutrition, or a specific carbohydrate diet, which restricts certain sugars. The goal is to determine if these diets can help manage the symptoms of active CD or UC. This trial may suit those diagnosed with CD or UC who have active symptoms and have recently had a colonoscopy confirming the disease's activity. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on CD and UC.

Will I have to stop taking my current medications?

The trial requires that any medications you are currently using for inflammatory bowel disease (IBD) must remain stable during the study, except for corticosteroids, which can be tapered off. This means you generally won't have to stop your current medications, but you should discuss any specific concerns with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the elemental diet and the specific carbohydrate diet (SCD) are generally safe for treating Crohn's disease and ulcerative colitis, though some differences exist.

For the elemental diet, studies indicate effectiveness for Crohn's disease with only minor side effects. Common issues include taste and social limitations, but serious problems are rare. This diet often helps improve symptoms and nutrition in people with Crohn's disease.

The specific carbohydrate diet also appears promising. Research suggests it can reduce symptoms in people with Crohn's disease and ulcerative colitis. Participants have reported feeling better, and it may even lower the risk of complications and hospital visits. Side effects are not commonly reported, making it a generally well-tolerated option.

Overall, both diets seem safe based on current research. However, personal experiences may vary, and consulting a doctor before starting any new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary therapies for Crohn's Disease and Ulcerative Colitis because they offer a different approach compared to typical medications like immunosuppressants or biologics. The elemental diet provides partially digested nutrients that can ease the digestive process and reduce inflammation while still providing 50% of daily caloric needs. On the other hand, the Specific Carbohydrate Diet focuses on eliminating complex carbs and sugars, potentially reducing symptoms by altering gut bacteria. These treatments might offer more natural and less invasive options for managing these conditions.

What evidence suggests that this trial's dietary treatments could be effective for Crohn's Disease and Ulcerative Colitis?

Research has shown that special diets can improve symptoms of Crohn's disease. Studies indicate these diets can reduce disease activity, enhance nutrition, and lower inflammation. Nearly 60% of patients on a similar diet remained symptom-free for two years.

In this trial, participants will join one of two dietary treatment arms. The elemental diet arm will provide 50% of daily caloric needs, while the specific carbohydrate diet (SCD) arm will meet 100% of caloric requirements. The specific carbohydrate diet may benefit people with Crohn's disease or ulcerative colitis, with about 47% of patients in studies reporting feeling better and showing improved lab results. Both diets aim to manage symptoms and enhance the quality of life for those with these conditions. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Established diagnosis of small bowel or colonic CD or ulcerative colitis

Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.

Confirmation of active CD or UC with recent (within 1 month) objective evidence of active disease on colonoscopy

Exclusion Criteria

Presence of stoma or J pouch

Presence of enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period

Bowel surgery within 12 weeks prior to screen and/or has surgery planned or deemed likely for IBD during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants adhere to a dietary therapy for 6 weeks, either a partial elemental diet or a specific carbohydrate diet

6 weeks

5 visits (in-person)

Follow-up

Participants are monitored for clinical, biochemical, nutritional, and microbiological parameters after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elemental diet
• Specific carbohydrate diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Elemental diet arm Active Control 1 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 arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Elemental diets, used alongside drug therapy, show therapeutic effectiveness in treating active Crohn's disease, particularly in cases of small bowel involvement, comparable to traditional treatments like salazosulfapyridine and corticosteroids.

The elemental diet leads to physiological changes that may contribute to its effectiveness, such as reduced gastric and pancreatic secretions, altered gut bacteria, and improved nutrient absorption, making it suitable for conditions like acute small bowel disease and malnourishment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Status of elemental diets in the therapy of Crohn disease in childhood]. Kirchmann, HM.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5329972/

Therapeutic Efficacy of an Elemental Diet for Patients with ... ED was effective in improving disease activity, nutritional status, and plasma amino acid levels, and thus it may be particularly effective for poorly nourished ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/7/6/460/452389

Exclusive elemental diet impacts on the gastrointestinal ... Conclusion: Treatment with four weeks elemental diet appeared to improve the symptoms of chronic pouchitis in some patients but is not an effective strategy for ...

3. cghjournal.org cghjournal.org/article/S1542-3565(19)31394-1/fulltext

Diet in Treatment of Inflammatory Bowel Diseases Enteral nutrition is effective in the treatment of pediatric patients with luminal Crohn's disease, but there have been few studies of the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4285926/

Elemental diet and the nutritional treatment of Crohn's ... A diet low in fat and fibre (LOFFLEX) has been shown to be highly effective with nearly 60% of patients in remission after 2 years (14). Foods involved vary ...

5. gastrojournal.org gastrojournal.org/article/0016-5085(91)90463-U/pdf

The Effect of Elemental Diet on Intestinal Permeability and ... This study examines whether treatment of acute. Crohn's disease with an elemental diet improves intestinal integrity and inflammation as assessed by.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415405/

Elemental Diet as a Therapeutic Modality Elemental diets offer a potentially highly efficacious dietary intervention with minor side effects. Palatability, cost, access, and social restrictions are ...

7. gastrojournal.org gastrojournal.org/article/S0016-5085(23)05597-X/fulltext

AGA Clinical Practice Update on Diet and Nutritional ... New data in Crohn's disease supports the use of enteral liquid nutrition to help induce remission and correct malnutrition in patients heading ...

8. fg.bmj.com fg.bmj.com/content/15/3/247

Role of diet in prevention versus treatment of Crohn's ... The role of diet to maintain remission in Crohn's disease and ulcerative colitis is unknown, so default to healthy eating guidelines is recommended.