Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
NCT ID: NCT07168499
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-09-15
2028-05-01
Brief Summary
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Researchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores.
Groups:
1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+/-2 weeks after the first intervention visit.
2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes).
3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes).
4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes).
All subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Group A - Combined diet + stress management
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.
Diet Management
Visit with IBD dietician for diet management specifically for IBD
Stress Management
Visit with IBD GI psychologist for stress management
Group B - Diet Alone
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).
Diet Management
Visit with IBD dietician for diet management specifically for IBD
Group C - Stress management alone
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).
Stress Management
Visit with IBD GI psychologist for stress management
Group D - Usual Care Arm
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).
No interventions assigned to this group
Interventions
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Diet Management
Visit with IBD dietician for diet management specifically for IBD
Stress Management
Visit with IBD GI psychologist for stress management
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Ashwin Ananthakrishnan
Principal Investigator and Clinical Professor
Principal Investigators
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Ashwin Ananthakrishnan, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN
Role: primary
Aarushi Gupta
Role: backup
Other Identifiers
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2025P001274
Identifier Type: -
Identifier Source: org_study_id