DAIN Diet for Crohn's Disease

(DAIN Trial)

Recruiting at 1 trial location

Overseen By Ana L Maldonado-Contreras, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must not be taking: Probiotics, Prednisone

Disqualifiers: Ostomy, Pregnancy, Obstruction, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

150 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. However, your medication doses should be stable for a certain period before screening: thiopurines, natalizumab, methotrexate for 12 weeks; anti-TNF, ustekinumab, vedolizumab for 8 weeks; 5-ASA for 2 weeks; and steroids for 1 week.

What data supports the idea that DAIN Diet for Crohn's Disease is an effective treatment?

The available research shows that dietary therapies, including the DAIN Diet, can be effective for Crohn's Disease. One study found that dietary strategies, like the Crohn's Disease Exclusion Diet, helped patients who were not responding to biological treatments. Another study highlighted that dietary changes could quickly lead to improvement and remission in children with active Crohn's Disease. Additionally, a meta-analysis indicated that combining specialized nutrition with medication increased the chances of remission compared to medication alone. These findings suggest that dietary approaches, such as the DAIN Diet, can be beneficial for managing Crohn's Disease. ^{1 2 3 4 5}

What safety data exists for the DAIN Diet for Crohn's Disease?

The research does not provide specific safety data for the DAIN Diet, but the Anti-Inflammatory Diet (IBD-AID), which is similar, is mentioned as a potential adjunct dietary therapy for inflammatory bowel disease. No direct safety data for the DAIN Diet is available in the provided research. ^{1 6 7 8 9}

Is the DAIN Diet a promising treatment for Crohn's Disease?

Yes, the DAIN Diet, also known as the Anti-Inflammatory Diet (IBD-AID), is a promising treatment for Crohn's Disease. It focuses on reducing inflammation by changing the types of carbohydrates and fats you eat and including foods that help good bacteria in your gut. This diet has shown potential as an additional way to help manage Crohn's Disease. ^{1 2 10 11 12}

What is the purpose of this trial?

The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.

Research Team

Ana L Maldonado-Contreras, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Eligibility Criteria

This trial is for adults aged 21-65 with mild to moderate Crohn's disease who are willing to significantly change their diet. Participants must have stable medication doses and be able to follow study procedures. Those on high-dose steroids, recent C. difficile colitis, ostomies, or using certain diets or probiotics within the last month cannot join.

Inclusion Criteria

My medication doses have been stable for the required time.

Willing and able to comply with specimen collection and other study procedures, and to complete the study

I am willing and able to make major changes to my diet.

Exclusion Criteria

I take more than 20mg of prednisone or its equivalent daily.

Ostomy

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial assessments and baseline data collection

1 week

1 visit (in-person)

Treatment

Participants in the experimental arm receive 10 weeks of DAIN intervention

10 weeks

4 visits (in-person or virtual) at weeks 0, 6, 10, and 14

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person or virtual) at week 14

Treatment Details

Interventions

• DAIN

Trial Overview The DAIN dietary intervention is being tested for its effectiveness in treating Crohn's disease symptoms. It adapts the IBD-AID™ by incorporating Puerto Rican food preferences while keeping key anti-inflammatory components intact.

Participant Groups

Group I: Arm1: Crohn's disease patients + DAIN Experimental Treatment 1 Intervention

Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)

Group II: Arm 2: Crohn's disease patients no intervention Active Control 1 Intervention

Participants will continue consuming their usual diet, with no intervention

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

University of Puerto Rico

Collaborator

Trials

69

Recruited

22,300+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Findings from Research

In a study of 40 patients with inflammatory bowel disease (IBD), 60% of those who followed the Anti-Inflammatory Diet (IBD-AID) reported good or very good responses, with all patients experiencing symptom reduction and the ability to discontinue at least one medication.

Among 11 patients reviewed in detail, significant improvements were observed in disease severity scores, with the Harvey Bradshaw Index decreasing from a mean of 11 to 1.5 and the Modified Truelove and Witts Severity Index dropping from 7 to 0 after following the diet for at least 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Olendzki, BC., Silverstein, TD., Persuitte, GM., et al.[2022]

In a study of 21 patients with Crohn's disease who lost response to biologic treatments, combining partial enteral nutrition with the Crohn's Disease Exclusion Diet led to clinical remission in 61.9% of participants after 6 weeks.

The treatment resulted in significant improvements in disease activity, with a notable decrease in the Harvey Bradshaw Index and C-reactive protein levels, suggesting that dietary strategies may be effective for patients who do not respond to traditional biologic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Therapy With the Crohn's Disease Exclusion Diet is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy. Sigall Boneh, R., Sarbagili Shabat, C., Yanai, H., et al.[2022]

In a study of 73 children with mild to moderate Crohn's disease, both the Crohn's Disease Exclusion Diet (CDED) and Exclusive Enteral Nutrition (EEN) led to a rapid clinical response, with 82% and 85% of patients showing improvement by week 3, respectively.

A rapid response to dietary therapy at week 3 significantly increased the likelihood of achieving clinical remission by week 6, suggesting that early dietary response can help predict long-term treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease. Sigall Boneh, R., Van Limbergen, J., Wine, E., et al.[2021]

Patients with inflammatory bowel disease (IBD) reported that certain foods, like yogurt, rice, and bananas, can improve their symptoms, while others, such as spicy foods, fried foods, and high-fiber items, are believed to worsen symptoms.

Patients with ostomies tended to consume more dairy and processed foods compared to those without ostomies, suggesting that dietary patterns may vary significantly among different IBD patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and self-reported associations of diet with symptoms of inflammatory bowel disease. Cohen, AB., Lee, D., Long, MD., et al.[2021]

A small study involving 56 patients with Crohn's disease showed no significant difference in remission rates between those on enteral nutrition and those with no dietary restrictions after 56 weeks, suggesting that diet may not heavily influence anti-TNF treatment outcomes.

A meta-analysis of 295 patients indicated that combining specialized enteral nutrition with Infliximab therapy significantly improved the odds of achieving and maintaining clinical remission compared to Infliximab alone, highlighting the potential role of diet in enhancing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Impact of Diet on Treatment Effect from Anti-TNF Drugs in Inflammatory Bowel Disease. Andersen, V., Hansen, AK., Heitmann, BL.[2022]

DA-6034 was well tolerated in a study involving 67 healthy volunteers, with no serious adverse events reported, indicating a good safety profile for this potential IBD treatment.

The drug showed minimal absorption into the bloodstream, suggesting that its local action in the gastrointestinal tract could be beneficial for treating inflammatory bowel disease (IBD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and tolerability of DA-6034, an anti-inflammatory agent, after single and multiple oral administrations in healthy volunteers. Lee, J., Shin, KH., Kim, JR., et al.[2021]

In a study involving 6290 patients with Crohn's disease, infliximab treatment did not show a higher mortality rate compared to other therapies, indicating its long-term safety in this regard.

While there was an observed increased risk for serious infections in infliximab-treated patients, this risk was more closely linked to factors like disease severity and the use of prednisone rather than infliximab itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Lichtenstein, GR., Feagan, BG., Cohen, RD., et al.[2022]

Diet and the microbiome may play a significant role in the development and management of Crohn's disease (CD) and Ulcerative Colitis (UC), with specific dietary therapies showing potential to induce remission in CD.

The International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) has compiled expert opinions to guide patients and physicians on dietary components that may help control or prevent relapses in inflammatory bowel diseases, addressing the current lack of clear dietary guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Guidance From the International Organization for the Study of Inflammatory Bowel Diseases. Levine, A., Rhodes, JM., Lindsay, JO., et al.[2021]

In a study of 6,273 Crohn's disease patients with an average follow-up of 5.2 years, infliximab treatment did not increase mortality risk compared to other treatments, indicating its long-term safety in this regard.

However, infliximab was associated with a higher risk of serious infections, although this risk was also influenced by the severity of the disease and the use of medications like prednisone and narcotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT™ registry. Lichtenstein, GR., Feagan, BG., Cohen, RD., et al.[2022]

A study involving 24 patients with Crohn's disease showed significant improvements in dietary habits after one year of following the Crohn's disease exclusion diet (CDED), including reduced intake of ultra-processed foods and increased consumption of healthier options like eggs, legumes, and nuts.

Patients demonstrated long-term adherence to the Mediterranean diet, indicating that dietary modifications can play a crucial role in managing Crohn's disease, although other factors also influence disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Habit Modifications in Paediatric Patients after One Year of Treatment with the Crohn's Disease Exclusion Diet. Martín-Masot, R., Herrador-López, M., Navas-López, VM.[2023]

In a pilot study involving 28 patients with active Crohn's disease, a nutritionally balanced formula (IBDNF) led to significant improvements in vitamin D levels and body composition after 4 months of use.

Patients with higher levels of eicosapentaenoic acid (EPA) from the IBDNF showed significantly lower disease activity and better quality of life, indicating that the formula may effectively enhance both nutritional status and disease management in Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an oral supplement enriched with fish oil, prebiotics, and antioxidants on nutrition status in Crohn's disease patients. Wiese, DM., Lashner, BA., Lerner, E., et al.[2021]

There is a rising prevalence of inflammatory bowel disease (IBD) globally, particularly among young people, highlighting the need for effective dietary recommendations to manage the condition.

The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) is working on developing nutrition guidelines, as the impact of various dietary components on IBD is complex and not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Interventions in Inflammatory Bowel Disease. Godala, M., Gaszyńska, E., Zatorski, H., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Dietary Therapy With the Crohn's Disease Exclusion Diet is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy. [2022]

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

Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease. [2021]

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

Dietary patterns and self-reported associations of diet with symptoms of inflammatory bowel disease. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Impact of Diet on Treatment Effect from Anti-TNF Drugs in Inflammatory Bowel Disease. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and tolerability of DA-6034, an anti-inflammatory agent, after single and multiple oral administrations in healthy volunteers. [2021]

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

Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. [2022]

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

Dietary Guidance From the International Organization for the Study of Inflammatory Bowel Diseases. [2021]

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

Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT™ registry. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Habit Modifications in Paediatric Patients after One Year of Treatment with the Crohn's Disease Exclusion Diet. [2023]

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

The effects of an oral supplement enriched with fish oil, prebiotics, and antioxidants on nutrition status in Crohn's disease patients. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Interventions in Inflammatory Bowel Disease. [2022]