DAIN Diet for Crohn's Disease

(DAIN Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special diet, called DAIN, might help people with Crohn's disease feel better and possibly enter remission, where symptoms reduce or disappear. The diet includes foods common in Puerto Rico, adjusted from an anti-inflammatory diet for inflammatory bowel disease. Participants will either follow the DAIN diet for 10 weeks or continue with their usual diet. Those who have had Crohn's disease for a while and find it affects their quality of life may be a good fit. As an unphased trial, this study offers a unique opportunity to explore new dietary approaches to improve quality of life for those with Crohn's disease.

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 prior data suggests that this dietary intervention is safe for Crohn's disease patients?

Research shows that the DAIN diet, designed for people with Crohn's disease, is generally easy to follow. Studies have found that certain diets can help people with inflammatory bowel diseases (IBD), such as Crohn's. The DAIN diet modifies the IBD Anti-Inflammatory Diet to include traditional Puerto Rican foods, making it more accessible for participants.

Early results indicate that participants have reacted well to the DAIN diet. They have enjoyed the meals and regularly attended counseling sessions. While researchers monitor and report side effects, no major issues have been noted so far.

These findings suggest that the DAIN diet is safe for participants, based on current research. However, those considering joining a trial should discuss possible risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DAIN Diet for Crohn's Disease because it offers a fresh, non-pharmaceutical approach to managing the condition. Unlike standard treatments like corticosteroids or immunosuppressants, which can carry significant side effects, the DAIN Diet focuses on dietary intervention. This diet has the potential to reduce inflammation and manage symptoms naturally, which could lead to fewer side effects and a more holistic way to control the disease. By addressing the condition through nutrition, DAIN could provide a new avenue for improving patient quality of life without relying on traditional medications.

What evidence suggests that the DAIN diet might be an effective treatment for Crohn's disease?

This trial will compare the effects of the DAIN diet with no dietary intervention for Crohn's disease patients. Research has shown that the DAIN diet, based on the IBD-AID™, might benefit individuals with Crohn's disease. Studies have found that dietary changes can reduce inflammation and improve symptoms in conditions like Crohn's. Adjusting gut bacteria through diet is considered a promising approach to managing these diseases. The DAIN diet includes foods familiar to Puerto Ricans, potentially making adherence easier. Early results suggest it could support clinical improvement and remission, helping patients feel better. ^{2 4 5 6 7}

Who Is on the Research Team?

Ana L Maldonado-Contreras, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10300087/

DietaAnti-Inflamatoria or DAIN: A Crohn's disease ... Diet has been increasingly shown to be of therapeutic benefit for patients with inflammatory bowel diseases (IBD), especially Crohn's disease (CD).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05627128?term=dietary%20treatment%20of%20ibd&viewType=Table&rank=3

A Culturally Tailored Dietary Intervention to Treat Crohn's ... Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, (iii) clinical response and remission,and (iii) dietary compliance.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8100370/

Anti-inflammatory diet and inflammatory bowel disease An alteration of gastrointestinal microbiota through dietary therapy was found to reduce IBD and is recognized as a promising therapeutic strategy for IBD. One ...

4. nutritionaltherapyforibd.org nutritionaltherapyforibd.org/news/ddw-2024-nutritional-highlights-part-1

DDW 2024 Highlights: IBD Diet and Non-Inflammatory ... Explore the latest research on diets for IBD and non-inflammatory symptoms, along with microbiome-directed personalized nutrition insights ...

5. gastrojournal.org gastrojournal.org/issue/S0016-5085(24)X6001-1?pageStart=49

May-May 2024 Mo1725 DIETA ANTI-INFLAMATORIA OR DAIN: A CROHN'S DISEASE MANAGEMENT STRATEGY TAILORED TO PUERTO RICANS ... OUTCOMES IN INFLAMMATORY BOWEL DISEASE.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001084

Dieta Anti-Inflamatoria or DAIN: A Crohn's disease ... Study safety and data management. Study design, implementation, and progress is evaluated quarterly. Adverse events are also monitored and promptly reported ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37388217/

DietaAnti-Inflamatoria or DAIN: A Crohn's disease ... Diet has been increasingly shown to be of therapeutic benefit for patients with inflammatory bowel diseases (IBD), especially Crohn's disease ( ...