RECRUITING

Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis

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Conditions

IBD (Inflammatory Bowel Disease)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-15
Study Completion:2028-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07168499

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
  2. 2. At least 18 years of age
  3. 3. Established diagnosis of CD, UC, or IBD-unspecified
  4. 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. 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. 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. 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.
  1. 1. Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
  2. 2. Initiation of advanced therapy for extra-intestinal symptoms alone
  3. 3. Known eating disorders
  4. 4. Already receiving dietary therapy or stress management interventions
  5. 5. Severe untreated psychiatric comorbidity including history of suicidal thoughts
  6. 6. Evidence of untreated infection (e.g. Clostridium difficile)
  7. 7. Presence of stoma or J-pouch
  8. 8. Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
  9. 9. On total parental nutrition (TPN) or already following a therapeutic diet for IBD.

Contacts and Locations

Study Contact

Emily A Nolan, DNP, MS, BA, PMHNP-BC, RN
CONTACT
617-724-7559
enolan4@mgb.org
Aarushi Gupta
CONTACT
agupta57@mgh.harvard.edu

Principal Investigator

Ashwin Ananthakrishnan, MD, MPH
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Ashwin Ananthakrishnan, MD, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15
Study Completion Date2028-05-01

Study Record Updates

Study Start Date2025-09-15
Study Completion Date2028-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • IBD (Inflammatory Bowel Disease)