Using vedolizumab to treat collagenous gastritis
Vedolizumab for the Treatment of Collagenous Gastritis
This study is testing if vedolizumab can help people with collagenous gastritis feel better and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | vedolizumab |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06317220 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of vedolizumab in patients diagnosed with collagenous gastritis. Participants will receive vedolizumab through intravenous infusions at specified intervals and will be monitored for symptom relief and overall health changes. The study includes regular surveys, blood sample collections, and endoscopic procedures with biopsies to assess treatment impact. The trial will last approximately one year for those who respond positively to the initial treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 or older with a biopsy-confirmed diagnosis of collagenous gastritis and experiencing moderate to severe symptoms.
Not a fit: Patients who are allergic to vedolizumab or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms for patients suffering from collagenous gastritis.
How similar studies have performed: While there is limited research specifically on vedolizumab for collagenous gastritis, similar biologic therapies have shown promise in treating other gastrointestinal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 14 or older * Weight of at least 40kg * Has a biopsy-confirmed diagnosis of collagenous gastritis * Agrees to all required study procedures * Presence of one or more collagenous gastritis symptom at a severity of Grade 1 or higher at the time of enrollment: abdominal pain, nausea, diarrhea, bloating, vomiting, flatulence, constipation, fatigue, headache, rash Exclusion Criteria: * Unable to independently provide informed consent or assent * Allergic to vedolizumab or any of its components
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Keri Sullivan
- Email: ksullivan79@mgh.harvard.edu
- Phone: 617-724-0195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.