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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: enolan4@mgb.org
• Phone: 617-724-7559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.