Is NCT05781152 recruiting in San Francisco, CA?

Yes, NCT05781152 is currently recruiting participants at its San Francisco, CA location. This crohn's disease clinical trial is actively enrolling qualified participants.

How do I join the crohn's disease clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Crohn's Disease Clinical Trial in San Francisco, CA

About This Crohn's Disease Study in San Francisco

Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children. While the exact cause of CD is not certain it is thought that the immune system located in the intestine reacts abnormally to the large number of bacteria contained there. The investigators think that diet, exposure to anti

Sponsor: Connecticut Children's Medical Center

Who Can Participate

Inclusion Criteria

Age ≥ 6 years and \< 18 years at enrollment

Suspected diagnosis of CD

Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patients presenting with diarrhea. If history of C. difficile then a minimum of 6 weeks duration from treatment start and negative repeat stool for C. difficile toxin.

Parent/guardian consent and patient assent

Ability to remain in follow-up for up to 6 months of initial observation followed by a minimum of 52 weeks after possible start of anti-TNF therapy Phase 1

Exclusion Criteria

Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation

Investigator judgment that patient has high likelihood (\>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with perforation, bowel obstruction from stricture)

Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)

Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling

Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)

Previous treatment with immunomodulators within one year of enrollment or anti-TNF therapy within two years of enrollment for other medical conditions (e.g., juvenile idiopathic arthritis)

Previous treatment with non-anti TNF biologics or small molecules for non-IBD indications in the past 6 months, with the exception of dupilumab (Dupixent) for asthma, eczema, or eosinophilic esophagitis

Inability to have MRE because of claustrophobia or other reasons Phase 2 Inclusion Criteria

Met all eligibility criteria for Phase 1 and participated in Phase 1

Diagnosed with macroscopic CD involving the terminal ileum and/or colon by endoscopic evaluation and/or MRE

MRE imaging within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy (TT). A limited 'research protocol' MRE is acceptable in participants who have undergone a clinical CTE during their initial diagnostic evaluation; see Manual of Procedures for details.

Received at least one of the following as initial therapy upon diagnosis:

Corticosteroids

Immunomodulator

Aminosalicylic acids (5-ASA)

Defined nutritional therapy

Anti-TNF (adalimumab or infliximab)

Commenced adalimumab or infliximab anti-TNF therapy guided by ROADMAB™ CDST as first therapy or within 180 days of diagnosis (TD), with or without concomitant immunomodulator 6 a. Had ileal and rectal biopsies, OR b. Ileal biopsies are not obtained secondary to inflammatory or structural changes at the ileocecal valve or distal ileum that prevent ileal intubation. To be acceptable for Phase 2, the following additional criteria must be met: b1. Gross inflammation or obvious narrowing at the IC valve or distal ileum as documented by the video colonoscopy, AND b2. MRE documentation of TI inflammation with or without narrowing, OR c. Ileal biopsies are not obtained secondary to inflammatory or structural changes due to colonic CD. 7\. Parent/guardian consent and patient assent 8. Ability to remain in follow-up for a minimum of 52 weeks after start of anti-TNF therapy Phase 2 Exclusion Criteria

Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy and normal MRE

Orofacial CD only

Esophageal, gastric, duodenal, and/or jejunal CD only

Severe complex fistulizing perianal disease +/- abscess, or perianal disease requiring surgical intervention or likely to require on-going surgical intervention possibly including diversion. The placement of a seton is not exclusionary. Incision and drainage of a perirectal abscess is also not exclusionary.

Perianal CD only with no evidence of luminal disease

Internal fistulizing disease at diagnosis

Initial IBD treatment with non-anti-TNF biologic or small molecule therapy

Received any anti-TNF agent other than adalimumab or infliximab

Investigator judgment that patient unlikely to return for clinical, endoscopic or MRE follow-up

Inability to have MRE because of claustrophobia or other reasons

Video of baseline endoscopy not available for central reading, unless otherwise approved by the Clinical Coordinating Center (Adequate photo documentation required)

Underwent bowel resection within 3 months of diagnosis (TD)

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 San Francisco?

Yes, this clinical trial (NCT05781152) has an active research site in San Francisco, CA 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.

Crohn's Disease Treatment Options in San Francisco, CA

If you're searching for crohn's disease treatment options in San Francisco, CA, this clinical trial (NCT05781152) 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 San Francisco research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced crohn's 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 crohn's disease clinical trials near you to find additional studies recruiting in your area.

Crohn's Disease Clinical Trial in San Francisco, CA

Expert Care in San Francisco

IRB Approved

No-Cost Care

Apply for This San Francisco Location

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