IBD (Inflammatory Bowel Disease)
Conditions
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 this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness/stress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC. 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.
Interventions
BEHAVIORALDiet Management
Visit with IBD dietician for diet management specifically for IBD
BEHAVIORALStress Management
Visit with IBD GI psychologist for stress management
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change marked by clinical remission of IBD | 12 weeks, 24 weeks | Subjects in the intervention arms will show clinically significant improvement in IBD symptoms after week 12 of the treatment period based upon disease activity scores using the Harvey-Bradshaw Disease Activity Index (HBI). For the HBI, a score less than 3 indicates remission while a score of 8-9 reflects severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical responses | 12 weeks, 24 weeks | A secondary objective is to evaluate if clinical response to medications is changed with the interventions as measured by the HBI disease activity index. |
| Change in patient illness perception about disease and self-reported outcomes | 12 weeks, 24 weeks | Subjects in the intervention arms will show clinically significant improvement in perception of IBD illness and self-reported outcomes after week 12 of the treatment period based upon Brief Illness Perception Questionnaire (B-IPQ) and Patient-Reported Outcomes Measurement Information System for Depression and Anxiety. For the B-IPQ, the lowest score is 0 and the highest is 10, with 10 indicating poorer overall view of illness. For both PROMIS questionnaires, a minimum score of 55 is within normal limits while scores above 70 are labelled as severe. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of intervention on change in fecal calprotectin levels between baseline and 12 weeks | 12 weeks | Fecal calprotein will be measured using standardized testing to assess levels at baseline and at 12 weeks to see if there is a change in levels. |
| Change in levels of blood tests | 12 weeks | Blood tests will be taken as part of standard of care and assessed for CBC with differential, comprehensive metabolic panel, C-reactive protein, ESR, serum iron studies, vitamin B12 level and processed for metagenomics to assess for changes post-intervention. |
Countries
United States
Contacts
Primary ContactEmily A Nolan, DNP, MS, BA, PMHNP-BC, RN
Backup ContactAarushi Gupta
Outcome results
None listed