Status:
RECRUITING
Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
Lead Sponsor:
Massachusetts General Hospital
Conditions:
IBD (Inflammatory Bowel Disease)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of thi...
Eligibility Criteria
Inclusion
- Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
- At least 18 years of age
- Established diagnosis of CD, UC, or IBD-unspecified
- Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)
- 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
- 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.
- 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
- Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
- Initiation of advanced therapy for extra-intestinal symptoms alone
- Known eating disorders
- Already receiving dietary therapy or stress management interventions
- Severe untreated psychiatric comorbidity including history of suicidal thoughts
- Evidence of untreated infection (e.g. Clostridium difficile)
- Presence of stoma or J-pouch
- Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
- On total parental nutrition (TPN) or already following a therapeutic diet for IBD.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07168499
Start Date
September 15 2025
End Date
May 1 2028
Last Update
November 6 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114