Boston, MANCT07168499Now EnrollingIRB Ready

IBD (Inflammatory Bowel Disease) Clinical Trial in Boston, MA

Access cutting-edge ibd (inflammatory bowel disease) treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Massachusetts General Hospital

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Expert Care in Boston

Access ibd (inflammatory bowel disease) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related ibd (inflammatory bowel disease) treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This IBD (Inflammatory Bowel Disease) Study in Boston

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.

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

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 Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07168499) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

IBD (Inflammatory Bowel Disease) Treatment Options in Boston, MA

If you're searching for ibd (inflammatory bowel disease) treatment options in Boston, MA, this clinical trial (NCT07168499) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced ibd (inflammatory bowel disease) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ibd (inflammatory bowel disease) clinical trials near you to find additional studies recruiting in your area.

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