BridgeMD
New treatment option for IBD (Inflammatory Bowel Disease)
Official title Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
ClinicalTrials.gov ID: NCT07168499
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Initiating advanced therapy (anti-TNF agents, anti-integrin agents, anti-IL12/23, anti-IL23 agents, S1P receptor modulators, JAK inhibitors) for IBD...
You likely can't join if
- 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)
See the full eligibility 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...
- 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 people or Simple Clinical Colitis Activity Index \> 2 at baseline (week 0) for UC people or having had a recent exacerbation...
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.