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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 the dietary therapy for Crohn's Disease and Ulcerative Colitis safe for humans?

Elemental diets, used for Crohn's disease, have been reported to cause physiological changes like decreased stomach and pancreas secretions and changes in gut bacteria, but no significant safety concerns have been noted in the studies reviewed. ^{1 2 3 4 5}

How does the elemental diet treatment for Crohn's disease differ from other treatments?

The elemental diet is unique because it provides nutrition in a simple, easily digestible form that reduces stress on the digestive system, potentially altering gut bacteria and reducing inflammation without the use of drugs. It is as effective as corticosteroids in inducing remission but is cheaper, simpler, and safer, and can be followed by a personalized food exclusion diet for long-term management. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Elemental diet, Specific carbohydrate diet for Crohn's Disease and Ulcerative Colitis?

Research shows that the Specific Carbohydrate Diet (SCD) can help control symptoms in people with Crohn's Disease and Ulcerative Colitis, although it may not fully reduce inflammation. Some studies found that children with Crohn's Disease experienced symptom relief on this diet, but it didn't completely heal the gut lining. ^{10 11 12 13 14}

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. England pubmed.ncbi.nlm.nih.gov

Dietary habits as risk factors for inflammatory bowel disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Response to strict and liberalized specific carbohydrate diet in pediatric Crohn's disease. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Working to Answer the Effectiveness of Nutrition in IBD: Still a Ways to Go. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical and Fecal Microbial Changes With Diet Therapy in Active Inflammatory Bowel Disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Durable Clinical and Biochemical but Not Endoscopic Remission in Pediatric Crohn's Disease on Specific Carbohydrate Diet Monotherapy. [2021]

6. Austria pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

[Adjuvant therapy with elemental diet in chronic inflammatory intestinal diseases. Comparative study]. [2013]

8. Japan pubmed.ncbi.nlm.nih.gov

Adherence to an elemental diet for preventing postoperative recurrence of Crohn's disease. [2018]

9. Norway pubmed.ncbi.nlm.nih.gov

Elemental versus polymeric enteral nutrition in paediatric Crohn's disease: a multicentre randomized controlled trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Impact of elemental diet on mucosal inflammation in patients with active Crohn's disease: cytokine production and endoscopic and histological findings. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Comparison of total parenteral nutrition and elemental diet in induction of remission of Crohn's disease. Long-term maintenance of remission by personalized food exclusion diets. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Treatment of active Crohn's disease by exclusion diet: East Anglian multicentre controlled trial. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Elemental diets in treatment of acute Crohn's disease. [2019]

14. Spain pubmed.ncbi.nlm.nih.gov

[Revision and consensus in nutritional therapy: nutrition in inflammatory intestinal diseases]. [2013]