Combining diet and stress-management with advanced treatments for Crohn's and ulcerative colitis

D-SCAPE - Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis - A Pragmatic Clinical Trial

This study will test whether adding diet guidance and stress-management support to advanced IBD medications helps people with active Crohn's disease or ulcerative colitis achieve and maintain remission.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07168499 on ClinicalTrials.gov

What this trial studies

This is a single-site, pragmatic, randomized trial at Massachusetts General Hospital that randomizes adults with active IBD who are starting advanced therapies into one of four groups to compare combinations of dietitian and GI-psychology support alongside medication. Participants must have recent objective evidence of active disease and will begin advanced therapy within two weeks of baseline. The interventions include targeted nutrition management and mindfulness/stress-management visits timed around the start of biologic or advanced drug induction, and disease activity scores will be used as primary outcomes. Non-biologic medications must remain stable during the treatment period except for corticosteroid tapering.

Who should consider this trial

Good fit: Adults (18+) with an established diagnosis of Crohn's disease, ulcerative colitis, or IBD-unspecified who have objective evidence of active disease and are initiating an advanced IBD therapy within two weeks of enrollment are the ideal candidates.

Not a fit: Patients with quiescent or very mild disease not starting advanced therapy, those without objective evidence of active inflammation, or those unable/unwilling to follow diet or psychosocial interventions are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, adding structured diet and stress-management care to advanced therapies could help patients reach remission faster, stay in remission longer, reduce symptoms, and potentially lower steroid use.

How similar studies have performed: Smaller trials and observational studies have shown that dietary changes and stress-management can improve symptoms and quality of life, but randomized data on combining these interventions with modern advanced therapies are limited.

Eligibility criteria

Inclusion Criteria:

1. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
2. At least 18 years of age
3. Established diagnosis of CD, UC, or IBD-unspecified
4. Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)
5. Initiating advanced therapy (anti-TNF agents, anti-integrin agents, anti-IL12/23, anti-IL23 agents, S1P receptor modulators, JAK inhibitors) for IBD per usual clinical care within 2 weeks of baseline/randomization, regardless of prior exposure to advanced therapies or disease duration
6. Other non-biologic IBD medications must remain stable during the treatment period and no medication changes are planned with the exception of tapering of corticosteroids.
7. Current disease activity defined as a Harvey Bradshaw index \> 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index \> 2 at baseline (week 0) for UC subjects or having had a recent exacerbation being treated with systemic steroids or budesonide.

Exclusion Criteria:

1. Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
2. Initiation of advanced therapy for extra-intestinal symptoms alone
3. Known eating disorders
4. Already receiving dietary therapy or stress management interventions
5. Severe untreated psychiatric comorbidity including history of suicidal thoughts
6. Evidence of untreated infection (e.g. Clostridium difficile)
7. Presence of stoma or J-pouch
8. Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
9. On total parental nutrition (TPN) or already following a therapeutic diet for IBD.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Ashwin Ananthakrishnan, MD, MPH — Massachusetts General Hospital
• Study coordinator: Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN

Conditions: IBD