Diet and Stress Management for Inflammatory Bowel Disease

(D-SCAPE Trial)

Overseen By Aarushi Gupta

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Anti-TNF, Anti-integrin

Disqualifiers: Eating disorders, Severe psychiatric, Infection, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining diet changes and stress management with advanced treatments can help manage Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. Researchers will test four different approaches to determine which most effectively reduces flare-ups. Participants will collaborate with dieticians and psychologists to assess if lifestyle changes improve their condition. The trial seeks individuals diagnosed with Crohn's Disease or Ulcerative Colitis who have recently experienced a flare-up and are starting new advanced therapies. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle interventions alongside advanced treatments to potentially improve the condition.

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

The trial requires that your current non-biologic IBD medications remain stable during the study, except for corticosteroids, which may be tapered off. You will also be starting advanced therapy for IBD as part of the trial.

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

Research has shown that combining diet and stress management can help manage symptoms of Inflammatory Bowel Disease (IBD). Studies have found that certain diets, such as the Mediterranean and low-FODMAP diets, may help control symptoms, while diets high in processed foods can worsen them.

Psychological treatments have been studied for their effects on stress, anxiety, and quality of life in IBD patients. These treatments are generally well-tolerated and might aid in managing the disease.

Diet and stress management typically do not cause serious side effects, but they may not work the same for everyone. Consulting a healthcare provider before starting any new treatment is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on holistic care for Inflammatory Bowel Disease (IBD) by combining diet and stress management. Unlike traditional treatments that mainly involve medications like anti-inflammatory drugs and immunosuppressants, this approach aims to address lifestyle factors that might contribute to IBD symptoms. The unique aspect here is the integration of personalized dietary guidance and stress-relief techniques, which could potentially offer more sustainable and side-effect-free symptom management. This trial may uncover how lifestyle adjustments can complement or even enhance current medical treatments, offering a fresh perspective on managing IBD.

What evidence suggests that this trial's treatments could be effective for IBD?

This trial will compare different approaches to managing Inflammatory Bowel Disease (IBD). Research has shown that combining diet changes and stress management can benefit people with IBD. Participants in this trial may receive a combination of diet and stress management, diet alone, or stress management alone. Studies indicate that stress worsens IBD symptoms for about 91% of patients, making stress management crucial. Techniques like mindfulness can reduce stress and improve life quality for those with IBD. Diet is also important because many patients find that certain foods trigger their symptoms. Reviews of different diets have shown they can lead to clinical remission, meaning symptoms are reduced or disappear. Together, these methods aim to lessen the frequency and severity of IBD symptom flare-ups. ^{1 2 6 7 8}

Who Is on the Research Team?

Ashwin Ananthakrishnan, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with active Crohn's Disease or Ulcerative Colitis. Participants will be involved in a study to see if lifestyle changes, like diet and stress management, combined with advanced therapies can help manage their condition.

Inclusion Criteria

I am 18 years old or older.

Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)

I am starting a new advanced IBD treatment soon.

Exclusion Criteria

I started treatment for symptoms outside my intestines.

Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study

Known eating disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive advanced therapy combined with lifestyle modifications (mindfulness/stress management + nutrition support) for induction and maintenance of clinical remission in CD and UC.

12 weeks

Initial visits with IBD dietician and/or IBD GI psychologist within the first month, followed by additional visits 4±2 weeks after the first intervention visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of clinical remission and changes in disease activity scores.

12 weeks

Visits for assessment of primary outcomes and optional blood and stool sample collection

Extension

Participants may continue to receive visits with IBD dietician and/or IBD GI psychologist after assessment of primary outcomes.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet and Stress Management Combined

Trial Overview The trial tests the effectiveness of combining diet and stress management with advanced therapy on disease activity scores in IBD patients. It has four groups receiving different combinations of interventions from an IBD dietician and GI psychologist at various stages.

How Is the Trial Designed?

Group I: Group D - Usual Care Arm Active Control 1 Intervention

Subjects will be offered a visit with an IBD GI psychologist and IBD dietician (whether in person or virtual) after 3 months (after assessment of our outcomes).

Group II: Group A - Combined diet + stress management Active Control 2 Interventions

Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist (whether in person or virtual) within the first month of advanced therapy initiation and another visit with each of the IBD dietician and the IBD GI psychologist 4+/- 2 weeks after first intervention visit.

Group III: Group B - Diet Alone Active Control 1 Intervention

Subjects will receive a visit with an IBD dietician (whether in person or virtual) within the first month of advanced therapy initiation and another visit with the IBD dietician 4+/-2 weeks after first intervention visit. They will be later offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes).

Group IV: Group C - Stress management alone Active Control 1 Intervention

Subjects will receive a visit with an IBD GI psychologist (whether in person or virtual) within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after first intervention visit. They will be later offered a visit with an IBD dietician after 3 months (after assessment of our primary outcomes).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11435346/

An Overview of Nutritional Interventions in Inflammatory ... This review aims to summarize the current data on the effect of different available diets on disease symptoms and the inflammatory process.

2. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1668590/full

a network meta-analysis of 15 interventions We identified 25 eligible studies evaluating 15 distinct dietary interventions in IBD patients. Using network meta-analysis, we assessed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405457725003092

From traditional to artificial intelligence-driven approaches ... Preliminary analyses demonstrated that participants receiving the CD-TDI intervention experienced significant reductions in gut inflammation and symptom ...

4. cghjournal.org cghjournal.org/article/S1542-3565(22)01106-5/fulltext

Dietary Interventions for the Treatment of Inflammatory ... IBD-related outcomes included clinical remission (absence of GI symptoms), change in calprotectin, endoscopic remission (absence of endoscopic ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/apt.18214

Review article: Evidence‐based dietary management of ... A gluten-free diet has been used by moderate proportions of patients in some geographical areas, but evidence for efficacy is anecdotal only.

6. academic.oup.com academic.oup.com/ecco-jcc/article/18/6/920/7475690

The Impact of Dietary Interventions on the Microbiota in ... Diet modulates the gut microbiota, and this may have implications for IBD; however, the body of evidence does not currently support clear dietary patterns or ...

7. mdpi.com mdpi.com/2072-6643/15/3/579

Dietary Exposures and Interventions in Inflammatory Bowel ... Exclusion and elimination diets are associated with improved symptoms in patients with IBD, but no effects on objective markers of inflammation. Specific ...

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

Anti-inflammatory diet and inflammatory bowel disease This review highlights the implications of AID on clinical outcomes of IBD patients. Lack of consistent data to support a practical recommendation of AID in ...